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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS EDMA CODE Company Instrument-Name Table of Contents Page Diagram: Instrument Classification Level 1 - 2 2 Instrument Classification Overview Level 1 - 3 3 Instrument Grouping 6 - Clinical Chemistry Instruments 6 - Immunochemistry Instruments 14 - Haematology Instruments 17 - Microbiology Instruments 22 - Other Clinical Instruments 23 - Data Management Systems 23 Alphabetical Order by Company 24 Alphabetical Order by Instrument Name 36 EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls Instruments Page 1 of 47 Revision 3 - April 1997

Table of Contents - dimdi.de · 21 01 01 Manual Photometer and Spectrophotometer 21 01 11 Dedicated Glucose Systems 7 21 01 12 Dedicated Glycated Haemoglobin /HbA1 Systems 21 01 19

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

Table of Contents

Page

Diagram: Instrument Classification Level 1 - 2 2

Instrument Classification Overview Level 1 - 3 3

Instrument Grouping 6

- Clinical Chemistry Instruments 6

- Immunochemistry Instruments 14 - Haematology Instruments 17

- Microbiology Instruments 22

- Other Clinical Instruments 23

- Data Management Systems 23

Alphabetical Order by Company 24

Alphabetical Order by Instrument Name 36

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 1 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

Diagram Instrument Classification Level 1 - 2

2

INSTRUMENTS

21CLINICAL CHEMISTRY

INSTRUMENTS

21

Chemistry Analyser

21 02

Blood Gas Analyser

21 03Electrophoresis

Equipment

21 04Chromatography

Equipment

21 05

Urine Analyser

21 06Self TestingEquipment

21 09Other Clin.Chem.

Instruments

22IMMUNOCHEMISTRY

INSTRUMENTS

22 01

RIA Equipment

22 02

Protein Analyser

22 03Immunoassay

Analyser

22 09Other Immunochem.

Instruments

23HAEMATOLOGYINSTRUMENTS

23 01Haemoglobin

Analyser

23 02

Blood Cell Counter

23 03

Flow Cytometer

23 04Coagulation

Systems

23 05Blood Grouping

Instruments

23 06Histology

Equipment

23 09Other Haematology

Instruments

24MICROBIOLOGYINSTRUMENTS

24 01BacteriologyInstruments

24 09Other Microbiology

Instruments

26OTHER CLINICAL

INSTRUMENTS

26 01

Clinical Centrifuges

26 02

Sample Processors

26 03

Washers

26 09Other Other

Clinical Instruments

27DATA MANAGEMENT

SYSTEMS

27 01

DMS Hardware

27 02DMS Software /Consumables

Level 1CATEGORIES

Level 2Groups

Level 3Subgroups

==> see following pages

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 2 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

Instrument Classification Overview Level 1 - 3 Page

2 INSTRUMENTS21 CLINICAL CHEMISTRY INSTRUMENTS 6

21 01 Chemistry Analyser21 01 01 Manual Photometer and Spectrophotometer21 01 11 Dedicated Glucose Systems 721 01 12 Dedicated Glycated Haemoglobin /HbA1 Systems21 01 19 Other Dedicated Single-Parameter CC Systems21 01 29 Dedicated Multi-Parameter CC Systems21 01 31 Small Manual and Semi-automated CC Systems21 01 32 Semi-automated CC Analyser21 01 41 Small Automated CC Analyser 821 01 42 Medium Automated CC Analyser 921 01 43 Large Automated CC Analyser21 01 44 Extra large Automated CC Analyser21 01 51 Electrolyte - Flame photometer 1021 01 52 Electrolyte/ISE only21 01 53 Electrolyte/ISE and other parameter

21 02 Blood Gas Analyser21 02 01 Blood Gas (p02 / pC02 + pH)21 02 02 Blood Gas and Electrolytes 1121 02 03 Blood Gas and CO-Oximeter21 02 04 Blood Gas, Electrolytes and CO-Oximeter21 02 06 Blood Gas, Electrolytes, CO-Oximeter and Other Parameters21 02 07 CO-Oximeter 21 02 09 Other Blood Gas Instruments

21 03 Electrophoresis Equipment 1221 03 01 Manual Electrophoresis21 03 02 Densitometers21 03 03 Automated integrated Electrophoresis Systems

21 04 Chromatography Equipment

21 05 Urine Analyser 1321 05 01 Manual Urine Analyzer21 05 02 Small Automated Urine Analyzer21 05 03 Medium Automated Urine Analyzer21 05 04 Large Automated Urine Analyzer

21 06 Self Testing Equipment (Clin.Chem.)21 06 01 Blood Glucose Meter21 06 02 Cholesterol Meter21 06 03 Lactate Meter21 06 11 Multiparameter CC Meter

21 09 Other Clinical Chemistry Instruments

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 3 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-NamePage

22 IMMUNOCHEMISTRY INSTRUMENTS 14

22 01 RIA Equipment22 01 01 RIA Counter

22 02 Protein Analyser22 02 01 Small Protein Analyser22 02 02 Large Protein Analyser

22 03 Immunoassay Analyser22 03 01 Manual I.A. Instruments / Readers22 03 02 Semi-automated I.A. Systems 1522 03 03 Automated I.A. Systems 1622 03 04 Batch / High throughput I.A. Systems22 03 05 Nucleic Acid Processors

22 09 Other Immunochemistry Instruments

23 HAEMATOLOGY INSTRUMENTS 17

23 01 Haemoglobin Analyser23 01 01 Dedicated Total Haemoglobin Analyser

23 02 Blood Cell Counter23 02 01 No differential Blood Cell Counter23 02 02 2 / 3 part differential Blood Cell Counter 1823 02 03 5 part differential low / medium end Blood Cell Counter23 02 04 5 part differential high end Blood Cell Counter 1923 02 11 Dedicated Reticulocyte Analyser

23 03 Flow Cytometer23 03 01 Flow Cytometer without Cell sorter23 03 02 Flow Cytometer with Cell sorter

23 04 Coagulation Systems 2023 04 01 Manual Coagulation Instruments23 04 02 Semi-automated Coagulation Systems23 04 03 Fully-automated Coagulation Systems 2123 04 04 Aggregometer23 04 05 Selftesting Equipment (Coagulation)

23 05 Blood Grouping Instruments23 05 01 Blood Grouping Instruments

23 06 Histology Equipment (excl.microscopes)23 06 01 General Histology Instruments23 06 02 Mictrotomes

23 09 Other Haematology Instruments23 09 01 Sediment rate Instruments

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 4 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-NamePage

24 MICROBIOLOGY INSTRUMENTS 22

24 01 Bacteriology Instruments24 01 01 Plate pouring Instruments24 01 02 Susceptibility and / or ID-systems24 01 03 Blood Culture Systems24 01 04 Dedicated Urine Screening MB Instruments 23

24 09 Other Microbiology Instruments

26 OTHER CLINICAL INSTRUMENTS

26 01 Clinical Centrifuges

26 02 Sample Processors26 02 01 Clinical Chemistry Sample Processors26 02 02 Immuno Assays Sample Processors26 02 03 Haematology Sample Processors26 02 04 Microbiology Sample Processors26 02 09 Multiple Purpose Sample Processors

26 03 Washers26 03 02 Immuno Assays Washers26 03 03 Haematology Washers26 03 09 Other Washers

26 09 Other Other Clinical Instruments

27 DATA MANAGEMENT SYSTEMS

27 01 Data Management Hardware

27 02 Data Management Software/Consumables

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 5 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-NameInstrument Grouping

2 INSTRUMENTS

21 CLINICAL CHEMISTRY INSTRUMENTS

21 01 Chemistry Analyser21 01 01 Manual Photometer and Spectrophotometer

Bayer ML 1ML2ML3

Beckman Model 42DU 5

BioMérieux UV-VIS JrUV-VIS 1UV-VIS 2VISUAL

BioSystems BTS 302BTS 305BTS 310

Boehringer Mannheim Photometer 4010Photometer 4020Photometer 5010

Eppendorf PCP 6121ECOM 6122ECOM 6124 F

Gilford 103203

Hycel ISISLange (Dr. Lange) LP 1

LP 3LP 6ALP 400LP 500Miniphotometer 8Miniphotometer 20

Merck EclipseEclipse Plus

Milton-Roy Spectronic 1001+ Spectronic 1101Spectronic 1201Spectronic 20 / 20 DSpectronic 21 DV Spectronic 21 MVSpectronic 21 UVDSpectronic 3000Spectronic 301Spectronic 401Spectronic 501Spectronic 601

Perkin-Elmer Lambda 11Lambda 12Lambda 14

Riele PMC 2000PM 210PM 310

Unicam PU 8610PU 8620

Vitatron IFPISP

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 6 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

21 01 11 Dedicated Glucose SystemsBeckman Glucose-Analyzer 2Eppendorf EBIO CompactRadiometer ABL System 625Yellow Springs YSI

21 01 12 Dedicated Glycated Haemoglobin /HbA1 Systems

ARKRAY KDK Hi-Auto A1c HA 8140Bayer DCA 2000Bio-Rad DIAMAT

DiaSTATVARIANT

Chiron GlycomatKontron NNMenarini HA 8110

HA 8121HA 8140

Merck Hitachi L 9000

21 01 19 Other Dedicated Single-Parameter CC Systems

Analox Instruments LM10Beckman Creatinine-Analyzer 2

Urea-Analyzer 2Elvilogos Bilirubinometer

21 01 29 Dedicated Multi-Parameter CC Systems

Analox Instruments P-GM7 micro-StatEppendorf EBIO Plus

21 01 31 Small Manual and Semi-automated CC SystemsAbbott VisionBayer SeralyzerBoehringer Mannheim Reflotron

Reflotron SprintCholestech L.D.XOrtho Diag. Systems (J&J) Vitros DT 60/Vitros DT60Eppendorf SPOTCHEMMenarini SPOTCHEMMerck EASY STRoche COBAS Ready (=SPOTCHEM)

21 01 32 Semi-automated CC Analyser

Beckman Clinical System 700BPC BioSED NNEppendorf EPAC 6140

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 7 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

21 01 41 Small Automated CC AnalyserAbbott ABA 100 / 200

VPSpectrum

Bayer RA 50RA 500RA 1000RA XT

Beckman AS 4 / AS 8Synchron CX3

Boehringer Mannheim AutolabHitachi 704Hitachi 705Hitachi 902Hitachi 904

Chimica Dianostica NaxosChiron EXPRESSDade (Dupont) Dimension 380

Dimension ESDiagnostic Testing PiccoloEppendorf ACP 5040

EASYEPOSELAN

Hycel LISA 200LISA 300

Instrumentation Laboratory Monarch 1000Kone Progress

Progress PlusSpecificSpecific SupraPro

Menarini Classic/ArtaxMerck SelectraOlympus AU 200Roche COBAS BIO

COBAS MIRACOBAS MIRA SCOBAS MIRA PLUSCOBAS FARACOBAS FARA II

Schiaparelli ACESigma SD2000Wako 20R

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 8 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

21 01 42 Medium Automated CC AnalyserAbbott EPxBayer RA2000

OPERABeckman Synchron CX 3 DELTA

Synchron CX 4Synchron CX 4 DELTASynchron CX 5Synchron CX 5 DELTA

Boehringer Mannheim Hitachi 911Coulter Optichem 500Eppendorf ERIS

ETECInstrumentation Laboratory Monarch PLUS

Monarch 2000Kone Delta

DynamicOptimaUltra

Hycel LISA 400Menarini Falcor 300

Falcor 600Nova NucleusOlympus AU 510

AU 560Ortho Diag. Systems (J&J) Vitros 250

Vitros 500Wako 30R

21 01 43 Large Automated CC AnalyserAmerican Monitor Perspective/ExcelBayer AXON

DAX 24DAX 48

Beckman Synchron CX 7 / CX7 DeltaBoehringer Mannheim Hitachi 717

Hitachi 917Dade (Dupont) Paramax-RX

Dimension 760Dimension ARDimension XL

Instrumentation Laboratory ILab 900Merck MEGAOlympus AU 600Ortho Diag. Systems (J&J) Vitros 750 XRC

Vitros 950 IRC/Vitros 950

Roche COBAS INTEGRA

21 01 44 Extra large Automated CC AnalyserBayer CHEM 1

DAX 72DAX 96

Boehringer Mannheim HIT 737HIT 747 Series

Instrumentation Laboratory ILab 1800Olympus AU 800

AU 1000AU 5000 SeriesAU 5200 Series

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 9 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

21 01 51 Electrolyte - Flame photometerHycel PHF 104

PHF 106Instrumentation Laboratory IL 943

21 01 52 Electrolyte/ISE only

AVL 9180 Electrolyte AnalyserBeckman E2AHycel EASYLYTEInstrumentation Laboratory IL 614, 644, 654YSI EasyLyte

21 01 53 Electrolyte/ISE and other parameterBeckman ELISE

21 02 Blood Gas Analyser

21 02 01 Blood Gas (p02 / pC02 + pH)AVL AVL 945

AVL 990AVL 995OPTI 1Compact 1Compact 2

Chiron CCD 238CCD 248CCD 278CCD 280CCD 840

Hewlett Packard i-STATInstrumentation Laboratory IL 1304

IL 1306IL 1312 IL 1420IL 1610IL 1620IL BG3

Nova Stat Profile 3Radiometer ABL 5

ABL 30ABL 300ABL 330ABL 500ABL 510ABL 520

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 10 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

21 02 02 Blood Gas and ElectrolytesChiron CCD 348

CCD 850CCD 860

Diametrics IRMAInstrumentation Laboratory IL 1400

IL 1405IL 1430IL 1630IL 1640IL 1650GEM PremierGEM STAT

GEM 6+GEM Premier Plus

Nova Biomedical Stat Profile1,2,4,5,7Stat Profile Plus 9,10Stat Profile Ultra

Radiometer ABL 4ABL 505ABL 620

AVL OMNI

21 02 03 Blood Gas and CO-Oximeter

21 02 04 Blood Gas, Electrolytes and CO-OximeterAVL OMNIChiron CCD 845

CCD 855Instrumentation Laboratory Synthesis 25 / 35Radiometer ABL 620

21 02 06 Blood Gas, Electrolytes, CO-Oximeter and Other ParametersChiron CCD 865Nova Stat Profile Ultra

21 02 07 CO-Oximeter AVL AVL 912Chiron CCD 270

CCD 815Instrumentation Laboratory IL 482

IL 682

Radiometer OSM 3

21 02 08 Osmometer

Gonotec Osomat 030/030DOsomat 050

Slamed Osmometer 800 clRoebling Micro-OsmometerVitech Scientific Model 3900Wescor Vapro

21 02 09 Sweat Analyzer

Wescor Sweat-Chek Analyzer

21 02 90 Other Blood Gas Instruments

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 11 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

21 03 Electrophoresis Equipment

21 03 01 Manual ElectrophoresisBeckman PARAGONCosmo FED 3200Helena NNSebia NN

21 03 02 DensitometersBeckman APPRAISEHelena NNOlympus Fractoscan

Fractoscan Junior

Sebia HYDRASYS

21 03 03 Automated integrated Electrophoresis SystemsBeckman APPRAISE

PARAGON CZE 2000Eppendorf (JOOKOO) CTE 1000

CTE 5000Helena Concept 2000

REPCardio REP

PRINCE-CEAUTOIFE

Menarini HS 7Olympus HITE SYSTEM 310

HITE SYSTEM 320HITE SYSTEM 620

Sebia HYDRASYS

21 04 Chromatography Equipment

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 12 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

21 05 Urine Analyser

21 05 01 Manual Urine AnalyserMenarini MiniAution

21 05 02 Small Automated Urine AnalyserBayer Clinitek 50

Clinitek 100Boehringer Mannheim Urilux

MinitronIMACO URIMAC

21 05 03 Medium Automated Urine AnalyserBayer Clinitek 200

Clinitek 200 +Boehringer Mannheim Miditron

Miditron JuniorUrotron RL 9

Behring RAPIMAT

21 05 04 Large Automated Urine AnalyserBayer Clinitek AtlasBoehringer Mannheim SupertronIRIS 900UDxMenarini SuperAutionSysmex UF-100Wako NNYeong Deong NN

21 06 Self Testing Equipment (Clin.Chem.)

21 06 01 Blood Glucose Meter

21 06 02 Cholesterol Meter

21 06 03 Lactate Meter

21 06 11 Multi-Parameter CC Meter

21 09 Other Clinical Chemistry Instruments

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 13 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

22 IMMUNOCHEMISTRY INSTRUMENTS

22 01 RIA Equipment

22 01 01 RIA Counter

22 02 Protein Analyser

22 02 01 Small Protein AnalyserBeckman ICSBehring TurbiTimerBio-Whittaker FiaxNycomed Card ReaderOrion Diagnostica Turbox

QuikRead 3

22 02 02 Large Protein AnalyserBayer DPA-1Behring BN 100

BNABN II

Beckman Array 2.0Array 360IMMAGE

Boehringer Mannheim KeySysSanofi Diagnostics Pasteur QM 300

22 03 Immunoassay Analyser

22 03 01 Manual I.A. Instruments / ReadersAbbott Matrix

QuantumQuantum II

Behring Elisa-PhotometerElisa-Reader 301Elisa-Reader 311Berilux 250Microtrack Reader SE SystemECOM 6123 D

Biochem Immunosystems Serazyme ISerazyme II

BioMerieux Axia MicroreaderAxia 2 Reader

Boehringer Mannheim ES 11ES 22ES 33

Chiron Magic Lite IDynatech System 5000Eppendorf ECOM 6123 DHybritech Photon IIMerck Eclair

LM-8Murex Micro ELISA Reader 7000

Micro ELISA MRX ReaderOrganon Teknika Microelisa Reader 100

Microelisa SystemOrtho Diagnostic Systems Auto Reader 3Sanofi Diagnostics Pasteur LP 400

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 14 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

22 03 02 Semi-automated I.A. SystemsAbbott ADx

IMx / IMx SelectTDx / TDxFLx

Behring BeriLux 400BEP IIOPUSOPUS PLUSETS PlusSolaris

Biochem Immunosystems SR 1BioMerieux VIDAS

Mini-VIDASBoehringer Mannheim ES 300

ElecSys 1010Byk-Sangtek LIA-mat S 300Chiron Magic Lite II

Magic Lite II+Magic Lite SQ Allergy System

Dade Stratus IStratus II

DPC Milenia MaxImmulite

Dade (Dupont) ACA IIIACA VACA SXACA STAR

Hybritech Photon EraOrtho Diag. Systems (J&J) AmerlitePharmacia UniCAPRadim BRIORoche COBAS EIA SystemSorin ETI-SYSTEMTosoh AIA 600Wallac / Pharmacia Delfia

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 15 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

22 03 03 Automated I.A. SystemsAbbott AxSYMBayer Immuno-IBehring OPUS MagnumBiochem Immunosystems LabotecBoehringer Mannheim ES 600

ES 700ElecSys 2010

Chiron ACS 180ACS 180 PLUSCentaur

CIS-Bio Cispack 4200DPC Immulite 2000Hycor HY-TEC 288Kone QuartusLisabio Ligand Immuno System AssayMerck (Biotrol) MAGIA 7000

MAGIA 8000Nichols Institute Diagnostic AdvantageOrganon Teknika TektimeOrtho Diag. Systems (J&J) Amerlite PC

Vitros ECiRadim ArioRoche COBAS CORE

COBAS CORE IIRosys Plato 1300Sanofi Diagnostics Pasteur AccessSorin ETI-LABTosoh AIA 1200Wallac / Pharmacia AutoDELFIA

Unicap 10022 03 04 Batch / High throughput I.A. Systems

Abbott Commander / FPCPRISM

Beckman ImmageBehring BEP III

BEP XL (Micro Trak XL)Bio-Rad RadiusBIO-TEK ELx808DPC / Biermann MAXDynatech System 7000Hamilton Microlab F.A.M.E.Hycor HY TEC EIA System Merck MIOSMurex DIAS System

MIAS SystemOrganon Teknika MPP 3000Ortho Diagnostic Systems SummitRosys Plato 3300Sanofi Diagnostics Pasteur AMS/LP 400

SonataSorin Omni System

22 03 05 Nucleic Acid ProcessorsAbbott LCxBecton Dickinson ProbeTecOrganon Teknika NASBA QR SystemPerkin Elmer GenAmp PCR system 2400Roche COBAS Amplicor

22 09 Other Immunochemistry Instruments

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 16 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

23 HAEMATOLOGY INSTRUMENTS

23 01 Haemoglobin Analyser

23 01 01 Dedicated Total Haemoglobin Analyser

23 02 Blood Cell Counter

23 02 01 No differential Blood Cell CounterAbbott CELL-DYN 300

CELL-DYN 400CELL-DYN 500CELL-DYN 610CELL-DYN 700CELL-DYN 800CELL-DYN 900

Becton-Dickinson QBC IQBC IIQBC Autoread

Biochmical Systems Hema-Check 5Biochem Immunosystems 130

15017075008000

Coulter CBC-5M430MD 8ZMM530

Kone AC 900AC 920

Nihon Kohden Celltak MEK-5100Sysmex F-520

F-820

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 17 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

23 02 02 2 / 3 part differential Blood Cell CounterAbbott CELL-DYN 1300

CELL-DYN 1400CELL-DYN 1600CELL-DYN 1700

Bayer H1JRCoulter T540

T660MD 16MD IIS770

Diatron TwincellHycel CELLY

HEMACELLKone AC 970Nihon Kohden Celltak Mini

Celltak-AutoRoche COBAS MICROS

COBAS MINOS STCOBAS MINOS STE COBAS MINOS STXCOBAS MINOS STEXCOBAS MINOS VET

Biochem Immunosystems 90009100 +9118 +9120 +

SEAC GENIUSSysmex K-800

K-1000

23 02 03 5 part differential low / medium end Blood Cell CounterAbbott CELL-DYN 2000Bayer H1Biochmical Systems Hema-Check 13Coulter JS

JRT890S880Onyx

Hycel HEMACELL PLUSRoche COBAS HELIOS LMG

COBAS HELIOS 5 Diff.Sysmex NE-1500

K-4500

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 18 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

23 02 04 5 part differential high end Blood Cell CounterAbbott CELL-DYN 3000

CELL-DYN 3500CELL-DYN 4000

Bayer H 1 EH 2H 3 RTCH 3 RTX

Coulter STKRSTKSMAXMSTGen S

Lisabio Hemacell/Hemacell PlusRoche COBAS ARGOS LMG

COBAS ARGOS 5 Diff.COBAS VEGA

Swelab AC920Sysmex SF-3000

SE-9000NE-8000

23 02 11 Dedicated Reticulocyte Analyser

Sysmex R-3000

Sediment rate analyser

COFIM SR 50Eurotec Medical System VT-50/VT-75/VT-100ALIFAX Test 1

23 03 Flow Cytometer

23 03 01 Flow Cytometer without Cell sorterBecton-Dickinson FACScan

FACStrakFACSCaliburFACSCount

Bio-Rad NNCoulter Epics Profile IIOrtho Diag. Systems (J&J) Cytoron AbsolutePartec CA-IISysmex R-2000/3000

23 03 02 Flow Cytometer with Cell sorterBecton-Dickinson FACStarPlus

FACSVantage FACSort

Coulter Epics ElitePartec PAS-II

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 19 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

23 04 Coagulation Systems

23 04 01 Manual Coagulation InstrumentsAmelung KC 4

KC 10KC 10A

Behnk CL4CL8

Behring Fibrintimer IIFibrintimer 10Chromotimer

BioMerieux Option 2-8Boehringer Mannheim Coaguchek/Coaguchek PlusERMA SSC-100Helena Cascade M-4Labor COA Data 1000-3000

COA SystemCOA Screener

Labsystems FP 900FP 910

LRE Coatron FCoatron F II

Nycomed ThrombotrackOrganon Teknika Coag-a-Mate XMOrtho Diagnostic Systems (MLA) Electra 700

Koagulab CTSRoche FibrometerStago STA 2

STA 4STA 8STA 888

Teco Medical Instruments Coachrome IV

23 04 02 Semi-automated Coagulation SystemsBiodata MCA 110Behnk Thrombolyzer ChromBoehringer Mannheim / Stago Coasys 110Helena Cascade 480Instrumentation Laboratory ACL 100

ACL 200ACL 300

ITC-International Technidyne ProTime Microcoagulation SystemLRE Coatron Jr.

Coatron FxOrganon Teknika Coag-A-Mate X2

Coag-A-Mate RA 4Ortho Diagnostic Systems (MLA) Electra 800

Electra 900Electra 900 CKoagulab 16-605

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 20 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

23 04 03 Fully-automated Coagulation SystemsAmelung KC 40Behnk Thrombolyser

Thromboyzer CombiBehring BFA

BCTBCS

BioMerieux HemolabBoehringer Mannheim / Stago STA

STA CompactChiron Biotrack 512Instrumentation Laboratory ACL 1000

ACL 2000ACL 3000ACL 3000pACL 6000ACL Futura

Organon Teknika Coag-A-Mate MDACoag-A-Mate MTX

Ortho Diagnostic Systems (MLA) Electra 1000 CElectra 1400 CElectra 1600 C

Stratec StracomatSysmex / Dade CA-1000

CA-5000CA-6000

23 04 04 AggregometerBiodata PAP 4Ortho Diag. Systems / Dade PFA-100

23 04 05 Selftesting Equipment (Coagulation)

23 05 Blood Grouping Instruments

23 05 01 Blood Grouping InstrumentsLifescreen QUASAR 240

QUASAR 400Menarini BOSSOlympus PK 80

PK 7100PK 7200

Ortho Diag. Systems (J&J) AutoVue

23 06 Histology Equipment (excl.microscopes)

23 06 01 General Histology Instruments

Pap Smear ScreeningNEOPATH AutoPap 300 QC System

23 06 02 Mictrotomes

23 09 Other Haematology Instruments

23 09 01 Sediment rate Instruments

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 21 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

24 MICROBIOLOGY INSTRUMENTS

24 01 Bacteriology Instruments

24 01 01 Plate pouring Instruments

24 01 02 Susceptibility and / or ID-systemsDade Touchscan

Autoscan 4 Microscan Walkaway 40Microscan Walkaway 96

Becton Dickinson SceptorAutosceptorSceptorpette

BioMerieux Vitek JuniorVitek 32Vitek 60Vitek 120Vitek 240mini APIUnisceptAladinATB Expression

Biokit VideobactDifco PascoI2R STRSCANMast Radius

MastascanRadiometer Sensititre

24 01 03 Blood Culture SystemsBecton Dickinson Bactec 460 Tb

Bactec 660Bactec 730Bactec 860Bactec 9000 MBBactec 9050Bactec 9120Bactec 9240

BioMerieux Vital 200Vital 1200

Difco SentinelESP

Organon Teknika BacT/Alert 120Organon Teknika BacT/Alert 240Sanofi Diagnostics Pasteur Bio Argos

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls InstrumentsPage 22 of 47 Revision 3 - April 1997

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

24 01 04 Dedicated Urine Screening MB InstrumentsBioMerieux Bact-T-Screen 2000

URIMATCoral Biotechnology Coral Wave 120Difco QuestorLumac Biocounter M2300

Biocounter M3000Orbec RamusSysmex UF-100

24 09 Other Microbiology Instruments

26 OTHER CLINICAL INSTRUMENTS

26 01 Clinical Centrifuges

26 02 Sample Processors

26 02 01 Clinical Chemistry Sample Processors

26 02 02 Immuno Assays Sample ProcessorsAbbott PPCBeckman BIOMEK 2000Ortho Diag. Systems (J&J) Summit Plus 2

Summit ProcessorSanofi Diagnostics Pasteur AMSSTecan GENESIS RSP 200

26 02 03 Haematology Sample Processors

26 02 04 Microbiology Sample Processors

26 02 09 Multiple Purpose Sample ProcessorsBoehringer Mannheim VS 250

PPV 120026 03 Washers

26 03 02 Immuno Assays Washers

26 03 03 Haematology Washers

26 03 09 Other Washers

26 09 Other Other Clinical Instruments

27 DATA MANAGEMENT SYSTEMS

27 01 Data Management Hardware

27 02 Data Management Software/Consumables

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

Alphabetical Order by Company

21 01 31 Abbott Vision21 01 41 Abbott ABA 100 / 20021 01 41 Abbott VP21 01 41 Abbott Spectrum21 01 42 Abbott EPx22 03 01 Abbott Matrix22 03 01 Abbott Quantum22 03 01 Abbott Quantum II22 03 02 Abbott ADx22 03 02 Abbott IMx / IMx Select22 03 02 Abbott TDx / TDxFLx22 03 03 Abbott AxSYM22 03 04 Abbott Commander / FPC22 03 04 Abbott PRISM22 03 05 Abbott LCx23 02 01 Abbott CELL-DYN 30023 02 01 Abbott CELL-DYN 40023 02 01 Abbott CELL-DYN 50023 02 01 Abbott CELL-DYN 61023 02 01 Abbott CELL-DYN 70023 02 01 Abbott CELL-DYN 80023 02 01 Abbott CELL-DYN 90023 02 02 Abbott CELL-DYN 130023 02 02 Abbott CELL-DYN 140023 02 02 Abbott CELL-DYN 160023 02 02 Abbott CELL-DYN 170023 02 03 Abbott CELL-DYN 200023 02 04 Abbott CELL-DYN 300023 02 04 Abbott CELL-DYN 350023 02 04 Abbott CELL-DYN 400026 02 02 Abbott PPC23 04 01 Amelung KC 423 04 01 Amelung KC 1023 04 01 Amelung KC 10A23 04 03 Amelung KC 4021 01 43 American Monitor Perspective/Excel21 02 01 AVL AVL 94521 02 01 AVL AVL 99021 02 01 AVL AVL 99521 02 01 AVL OPTI 121 02 01 AVL Compact 121 02 01 AVL Compact 221 02 04 AVL OMNI21 02 07 AVL AVL 91221 01 01 Bayer ML 121 01 01 Bayer ML221 01 01 Bayer ML321 01 12 Bayer DCA 200021 01 31 Bayer Seralyzer21 01 42 Bayer RA200021 01 42 Bayer OPERA21 01 43 Bayer AXON

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name21 01 43 Bayer DAX 2421 01 43 Bayer DAX 4821 01 44 Bayer CHEM 121 01 44 Bayer DAX 7221 01 44 Bayer DAX 9621 05 02 Bayer Clinitek 5021 05 02 Bayer Clinitek 10021 05 03 Bayer Clinitek 20021 05 03 Bayer Clinitek 200 +21 05 04 Bayer Clinitek Atlas22 02 02 Bayer DPA-122 03 03 Bayer Immuno-I23 02 02 Bayer H1JR23 02 03 Bayer H123 02 04 Bayer H 1 E23 02 04 Bayer H 223 02 04 Bayer H 3 RTC23 02 04 Bayer H 3 RTX21 01 41 Bayer RA 5021 01 41 Bayer RA 50021 01 41 Bayer RA 100021 01 41 Bayer RA XT21 01 01 Beckman Model 4221 01 01 Beckman DU 521 01 11 Beckman Glucose-Analyzer 221 01 19 Beckman Creatinine-Analyzer 221 01 19 Beckman Urea-Analyzer 221 01 32 Beckman Clinical System 70021 01 41 Beckman AS 4 / AS 821 01 41 Beckman Synchron CX321 01 42 Beckman Synchron CX 3 DELTA21 01 42 Beckman Synchron CX 421 01 42 Beckman Synchron CX 4 DELTA21 01 42 Beckman Synchron CX 521 01 42 Beckman Synchron CX 5 DELTA21 01 43 Beckman Synchron CX 721 01 43 Beckman Synchron CX 7 DELTA21 01 52 Beckman E2A21 01 53 Beckman ELISE21 03 01 Beckman PARAGON21 03 02 Beckman APPRAISE21 03 03 Beckman PARAGON CZE 200022 02 01 Beckman ICS22 02 02 Beckman Array 2.022 02 02 Beckman Array 36022 02 02 Beckman IMMAGE26 02 02 Beckman BIOMEK 200022 03 05 Becton Dickinson ProbeTec24 01 02 Becton Dickinson Sceptor24 01 02 Becton Dickinson Sceptorpette24 01 03 Becton Dickinson Bactec 460 Tb24 01 03 Becton Dickinson Bactec 66024 01 03 Becton Dickinson Bactec 73024 01 03 Becton Dickinson Bactec 860

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name24 01 03 Becton Dickinson Bactec 9000 MB24 01 03 Becton Dickinson Bactec 905024 01 03 Becton Dickinson Bactec 912024 01 03 Becton Dickinson Bactec 924023 02 01 Becton-Dickinson QBC I23 02 01 Becton-Dickinson QBC II23 02 01 Becton-Dickinson QBC Autoread23 03 01 Becton-Dickinson FACScan23 03 01 Becton-Dickinson FACStrak23 03 01 Becton-Dickinson FACSCalibur23 03 01 Becton-Dickinson FACSCount23 03 02 Becton-Dickinson FACStarPlus

23 03 02 Becton-Dickinson FACSVantage 23 03 02 Becton-Dickinson FACSort23 04 01 Behnk CL423 04 01 Behnk CL823 04 03 Behnk Thrombolyser21 05 03 Behring RAPIMAT22 02 01 Behring TurbiTimer22 02 02 Behring BN 10022 02 02 Behring BNA22 02 02 Behring BN II22 03 01 Behring Elisa-Photometer22 03 01 Behring Elisa-Reader 30122 03 01 Behring Elisa-Reader 31122 03 01 Behring Berilux 25022 03 01 Behring Microtrack Reader SE System

22 03 01 Behring ECOM 6123 D22 03 02 Behring BeriLux 40022 03 02 Behring BEP II22 03 02 Behring OPUS22 03 02 Behring OPUS PLUS22 03 02 Behring ETS Plus22 03 02 Behring Solaris22 03 03 Behring OPUS Magnum22 03 04 Behring BEP III22 03 04 Behring BEP XL (Micro Trak XL)23 04 01 Behring Fibrintimer II23 04 01 Behring Fibrintimer 1023 04 01 Behring Chromotimer23 04 03 Behring BFA23 04 03 Behring BCT23 04 03 Behring BCS21 01 12 Bio-Rad DIAMAT21 01 12 Bio-Rad VARIANT22 03 04 Bio-Rad Radius22 03 04 BIO-TEK ELx80822 02 01 Bio-Whittaker Fiax22 03 01 Biochem Immunosystems Serazyme I22 03 01 Biochem Immunosystems Serazyme II22 03 02 Biochem Immunosystems SR 122 03 03 Biochem Immunosystems Labotec23 02 01 Biochem Immunosystems 13023 02 01 Biochem Immunosystems 150

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name23 02 01 Biochem Immunosystems 17023 02 01 Biochem Immunosystems 750023 02 01 Biochem Immunosystems 800023 02 02 Biochem Immunosystems 900023 02 02 Biochem Immunosystems 9100 +23 02 02 Biochem Immunosystems 9118 +23 02 02 Biochem Immunosystems 9120 +23 04 02 Biodata MCA 11023 04 04 Biodata PAP 424 01 02 Biokit Videobact22 03 01 BioMerieux Axia Microreader22 03 01 BioMerieux Axia 2 Reader22 03 02 BioMerieux VIDAS22 03 02 BioMerieux Mini-VIDAS23 04 01 BioMerieux Option 2-823 04 03 BioMerieux Hemolab24 01 02 BioMerieux Vitek Junior24 01 02 BioMerieux Vitek 3224 01 02 BioMerieux Vitek 6024 01 02 BioMerieux Vitek 12024 01 02 BioMerieux Vitek 24024 01 02 BioMerieux Uniscept24 01 02 BioMerieux Aladin24 01 02 BioMerieux ATB Expression24 01 03 BioMerieux Vital 20024 01 03 BioMerieux Vital 1200 24 01 04 BioMerieux Bact-T-Screen 200024 01 04 BioMerieux URIMAT21 01 01 BioSystems BTS 30221 01 01 BioSystems BTS 30521 01 01 BioSystems BTS 31021 01 01 Boehringer Mannheim Photometer 401021 01 01 Boehringer Mannheim Photometer 402021 01 31 Boehringer Mannheim Reflotron21 01 31 Boehringer Mannheim Reflotron Sprint21 01 41 Boehringer Mannheim Hitachi 70421 01 41 Boehringer Mannheim Hitachi 70521 01 41 Boehringer Mannheim Hitachi 90421 01 42 Boehringer Mannheim Hitachi 91121 01 43 Boehringer Mannheim Hitachi 71721 01 43 Boehringer Mannheim Hitachi 91721 01 44 Boehringer Mannheim HIT 73721 01 44 Boehringer Mannheim HIT 747 Series21 05 02 Boehringer Mannheim Urilux21 05 02 Boehringer Mannheim Minitron21 05 03 Boehringer Mannheim Miditron21 05 03 Boehringer Mannheim Miditron Junior21 05 03 Boehringer Mannheim Urotron RL 921 05 04 Boehringer Mannheim Supertron22 02 02 Boehringer Mannheim KeySys22 03 01 Boehringer Mannheim ES 1122 03 01 Boehringer Mannheim ES 2222 03 01 Boehringer Mannheim ES 3322 03 02 Boehringer Mannheim ES 300

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name22 03 02 Boehringer Mannheim ElecSys 101022 03 03 Boehringer Mannheim ES 60022 03 03 Boehringer Mannheim ES 70022 03 03 Boehringer Mannheim ElecSys 201026 02 09 Boehringer Mannheim PPV23 04 02 Boehringer Mannheim / Stago Coasys 11023 04 03 Boehringer Mannheim / Stago STA23 04 03 Boehringer Mannheim / Stago STA Compact22 03 02 Byk-Sangtek LIA-mat S 30021 01 12 Chiron (Ciba Corning) Glycomat21 01 41 Chiron (Ciba Corning) EXPRESS21 02 01 Chiron (Ciba Corning) CCD 23821 02 01 Chiron (Ciba Corning) CCD 24821 02 01 Chiron (Ciba Corning) CCD 27821 02 01 Chiron (Ciba Corning) CCD 28021 02 01 Chiron (Ciba Corning) CCD 84021 02 02 Chiron (Ciba Corning) CCD 34821 02 02 Chiron (Ciba Corning) CCD 85021 02 02 Chiron (Ciba Corning) CCD 86021 02 04 Chiron (Ciba Corning) CCD 84521 02 04 Chiron (Ciba Corning) CCD 85521 02 04 Chiron (Ciba Corning) CCD 86521 02 06 Chiron (Ciba Corning) CCD 86521 02 07 Chiron (Ciba Corning) CCD 27021 02 07 Chiron (Ciba Corning) CCD 81522 03 01 Chiron (Ciba Corning) Magic Lite I22 03 02 Chiron (Ciba Corning) Magic Lite II22 03 02 Chiron (Ciba Corning) Magic Lite II+22 03 02 Chiron (Ciba Corning) Magic Lite SQ Allergy System

22 03 03 Chiron (Ciba Corning) ACS 18022 03 03 Chiron (Ciba Corning) ACS 180 PLUS23 04 03 Chiron (Ciba Corning) Biotrack 51221 01 31 Cholestech L.D.X22 03 03 CIS-Bio Cispack 420024 01 04 Coral Biotechnology Coral Wave 12021 03 01 COSMO FED 320021 01 42 Coulter Optichem 50023 02 01 Coulter CBC-523 02 01 Coulter M43023 02 01 Coulter MD 823 02 01 Coulter ZM23 02 01 Coulter M53023 02 02 Coulter T54023 02 02 Coulter T66023 02 02 Coulter MD 1623 02 02 Coulter MD II23 02 02 Coulter S77023 02 03 Coulter JS23 02 03 Coulter JR23 02 03 Coulter T89023 02 03 Coulter S88023 02 03 Coulter Onyx23 02 04 Coulter STKR23 02 04 Coulter STKS

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name23 02 04 Coulter MAXM23 02 04 Coulter ST23 03 01 Coulter Epics Profile II23 03 02 Coulter Epics Elite22 03 02 Dade Stratus I22 03 02 Dade Stratus II24 01 02 Dade Touchscan 24 01 02 Dade Autoscan 4 24 01 02 Dade Microscan Walkaway 4024 01 02 Dade Microscan Walkaway 9624 01 02 Dade Autosceptor21 01 41 Dade (Dupont) Dimension 38021 01 41 Dade (Dupont) Dimension ES21 01 43 Dade (Dupont) Paramax-RX21 01 43 Dade (Dupont) Dimension 76021 01 43 Dade (Dupont) Dimension AR21 01 43 Dade (Dupont) Dimension XL22 03 02 Dade (Dupont) ACA III22 03 02 Dade (Dupont) ACA V22 03 02 Dade (Dupont) ACA SX22 03 02 Dade (Dupont) ACA STAR21 02 02 Diametrics IRMA24 01 02 Difco Pasco24 01 03 Difco Sentinel24 01 03 Difco ESP24 01 04 Difco Questor22 03 02 DPC Milenia Max22 03 02 DPC Immulite22 03 04 DPC / Biermann MAX22 03 01 Dynatech System 500022 03 04 Dynatech System 700021 01 01 Eppendorf PCP 612121 01 01 Eppendorf ECOM 612221 01 01 Eppendorf ECOM 6124 F21 01 11 Eppendorf EBIO Compact21 01 29 Eppendorf EBIO Plus21 01 31 Eppendorf SPOTCHEM21 01 32 Eppendorf EPAC 614021 01 41 Eppendorf ACP 504021 01 41 Eppendorf EASY21 01 41 Eppendorf EPOS21 01 41 Eppendorf ELAN21 01 42 Eppendorf ERIS21 01 42 Eppendorf ETEC22 03 01 Eppendorf ECOM 6123 D21 03 03 Eppendorf (JOKOO) CTE 100021 03 03 Eppendorf (JOKOO) CTE 500021 01 01 Gilford 10321 01 01 Gilford 20322 03 04 Hamilton Microlab F.A.M.E.21 03 01 Helena NN21 03 02 Helena NN21 03 03 Helena Concept 200021 03 03 Helena REP

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name21 03 03 Helena Cardio REP21 03 03 Helena PRINCE-CE23 04 01 Helena Cascade M-423 04 02 Helena Cascade 48022 03 01 Hybritech Photon II22 03 02 Hybritech Photon Era24 01 02 I2R STRSCAN21 05 02 IMACO URIMAC21 01 41 Instrument. Lab. (IL) Monarch 100021 01 42 Instrument. Lab. (IL) Monarch PLUS21 01 42 Instrument. Lab. (IL) Monarch 200021 01 43 Instrument. Lab. (IL) ILab 90021 01 44 Instrument. Lab. (IL) ILab 180021 01 51 Instrument. Lab. (IL) IL 94321 01 52 Instrument. Lab. (IL) IL 614, 644, 65421 02 01 Instrument. Lab. (IL) IL 130421 02 01 Instrument. Lab. (IL) IL 130621 02 01 Instrument. Lab. (IL) IL 1312 21 02 01 Instrument. Lab. (IL) IL 142021 02 01 Instrument. Lab. (IL) IL 161021 02 01 Instrument. Lab. (IL) IL 162021 02 01 Instrument. Lab. (IL) IL BG321 02 02 Instrument. Lab. (IL) IL 1400 21 02 02 Instrument. Lab. (IL) IL 140521 02 02 Instrument. Lab. (IL) IL 143021 02 02 Instrument. Lab. (IL) IL 163021 02 02 Instrument. Lab. (IL) IL 164021 02 02 Instrument. Lab. (IL) IL 165021 02 02 Instrument. Lab. (IL) GEM PREMIER21 02 02 Instrument. Lab. (IL) GEM STAT21 02 02 Instrument. Lab. (IL) GEM 6+21 02 02 Instrument. Lab. (IL) GEM PREMIER PLUS21 02 04 Instrument. Lab. (IL) Synthesis 25 /3521 02 07 Instrument. Lab. (IL) IL 48221 02 07 Instrument. Lab. (IL) IL 68223 04 02 Instrument. Lab. (IL) ACL 10023 04 02 Instrument. Lab. (IL) ACL 20023 04 02 Instrument. Lab. (IL) ACL 30023 04 03 Instrument. Lab. (IL) ACL 100023 04 03 Instrument. Lab. (IL) ACL 200023 04 03 Instrument. Lab. (IL) ACL 300023 04 03 Instrument. Lab. (IL) ACL 3000p23 04 03 Instrument. Lab. (IL) ACL 600023 04 03 Instrument. Lab. (IL) ACL Futura21 01 41 Kone Progress21 01 41 Kone Progress Plus21 01 41 Kone Specific21 01 41 Kone Specific Supra21 01 42 Kone Delta21 01 42 Kone Dynamic21 01 42 Kone Optima21 01 42 Kone Ultra 23 02 01 Kone AC 90023 02 01 Kone AC 920

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name23 02 02 Kone AC 97022 03 03 Kone Quartus23 04 01 Labor COA Data 1000-300023 04 01 Labor COA System23 04 01 Labor COA Screener23 04 01 Labsystems FP 90023 04 01 Labsystems FP 91021 01 01 Lange (Dr. Lange) LP 121 01 01 Lange (Dr. Lange) LP 321 01 01 Lange (Dr. Lange) LP 6A21 01 01 Lange (Dr. Lange) LP 40021 01 01 Lange (Dr. Lange) LP 50021 01 01 Lange (Dr. Lange) Miniphotometer 823 05 01 Lifescreen QUASAR 24023 05 01 Lifescreen QUASAR 40023 04 01 LRE Coatron F23 04 01 LRE Coatron F II23 04 02 LRE Coatron Jr.23 04 02 LRE Coatron Fx24 01 04 Lumac Biocounter M230024 01 04 Lumac Biocounter M300024 01 02 Mast Radius24 01 02 Mast Mastascan21 01 12 Menarini HA 811021 01 12 Menarini HA 812121 01 12 Menarini HA 814021 01 31 Menarini SPOTCHEM21 01 41 Menarini Classic/Artax21 01 42 Menarini Falcor 30021 01 42 Menarini Falcor 60021 03 03 Menarini HS 721 05 01 Menarini MiniAution21 05 04 Menarini SuperAution23 05 01 Menarini BOSS21 01 01 Merck Eclipse21 01 01 Merck Eclipse Plus21 01 12 Merck Hitachi L 900021 01 31 Merck EASY ST21 01 41 Merck Selectra21 01 43 Merck MEGA22 03 01 Merck Eclair22 03 01 Merck LM-822 03 04 Merck MIOS22 03 03 Merck (Biotrol) MAGIA 700022 03 03 Merck (Biotrol) MAGIA 800021 01 01 Milton-Roy Spectronic 1001+ 21 01 01 Milton-Roy Spectronic 110121 01 01 Milton-Roy Spectronic 120121 01 01 Milton-Roy Spectronic 20 / 20 D21 01 01 Milton-Roy Spectronic 21 DV 21 01 01 Milton-Roy Spectronic 21 MV21 01 01 Milton-Roy Spectronic 21 UVD21 01 01 Milton-Roy Spectronic 300021 01 01 Milton-Roy Spectronic 301

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name21 01 01 Milton-Roy Spectronic 40121 01 01 Milton-Roy Spectronic 50121 01 01 Milton-Roy Spectronic 60122 03 01 Murex Micro ELISA Reader 700022 03 01 Murex Micro ELISA MRX Reader22 03 04 Murex DIAS System22 03 04 Murex MIAS System23 02 01 Nihon Kohden Celltak MEK-510023 02 02 Nihon Kohden Celltak-Auto21 01 42 Nova Nucleus21 02 01 Nova Stat Profile 321 02 02 Nova Biomedical Stat Profile1,2,4,5,721 02 02 Nova Biomedical Stat Profile Plus 9,1022 02 01 Nycomed Card Reader23 04 01 Nycomed Thrombotrack21 01 41 Olympus AU 20021 01 42 Olympus AU 51021 01 42 Olympus AU 56021 01 43 Olympus AU 60021 01 44 Olympus AU 800 21 01 44 Olympus AU 100021 01 44 Olympus AU 5000 Series21 01 44 Olympus AU 5200 Series21 03 02 Olympus Fractoscan21 03 02 Olympus Fractoscan Junior21 03 03 Olympus HITE SYSTEM 31021 03 03 Olympus HITE SYSTEM 32021 03 03 Olympus HITE SYSTEM 62023 05 01 Olympus PK 8023 05 01 Olympus PK 710023 05 01 Olympus PK 720024 01 04 Orbec Ramus23 04 01 Organon Teknika Coag-a-Mate XM22 03 01 Organon Teknika Microelisa Reader 10022 03 01 Organon Teknika Microelisa System22 03 02 Organon Teknika Auraflex22 03 03 Organon Teknika Tektime22 03 04 Organon Teknika MPP 300022 03 05 Organon Teknika NASBA QR System23 04 02 Organon Teknika Coag-A-Mate X223 04 02 Organon Teknika Coag-A-Mate RA 423 04 03 Organon Teknika Coag-A-Mate MDA23 04 03 Organon Teknika Coag-A-Mate MTX24 01 03 Organon Teknika BacT/Alert 12024 01 03 Organon Teknika BacT/Alert 24022 02 01 Orion Diagnostica Turbox22 02 01 Orion Diagnostica QuikRead 321 01 31 Ortho Diag.Syst. (J&J) VITROS(Ektachem) DT 6021 01 42 Ortho Diag.Syst. (J&J) VITROS(Ektachem) 25021 01 42 Ortho Diag.Syst. (J&J) VITROS(Ektachem) 50021 01 43 Ortho Diag.Syst. (J&J) VITROS(Ektachem) 750 XRC21 01 43 Ortho Diag.Syst. (J&J) VITROS(Ektachem) 950 IRC22 03 02 Ortho Diag.Syst. (J&J) Amerlite22 03 03 Ortho Diag.Syst. (J&J) Amerlite PC

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name22 03 03 Ortho Diag.Syst. (J&J) VITROS ECI23 03 01 Ortho Diag.Syst. (J&J) Cytoron Absolute26 02 02 Ortho Diag.Syst. (J&J) Summit Plus 226 02 02 Ortho Diag.Syst. (J&J) Summit Processor22 03 01 Ortho Diagnostic Systems Auto Reader 322 03 04 Ortho Diagnostic Systems Summit23 04 01 Ortho Diagnostic Systems (MLA) Electra 70023 04 01 Ortho Diagnostic Systems (MLA) Koagulab CTS23 04 02 Ortho Diagnostic Systems (MLA) Electra 80023 04 02 Ortho Diagnostic Systems (MLA) Electra 90023 04 02 Ortho Diagnostic Systems (MLA) Electra 900 C23 04 02 Ortho Diagnostic Systems (MLA) Koagulab 16-60523 04 03 Ortho Diagnostic Systems (MLA) Electra 1000 C23 04 03 Ortho Diagnostic Systems (MLA) Electra 1400 C23 04 03 Ortho Diagnostic Systems (MLA) Electra 1600 C23 04 04 Ortho Diagnostic Systems / Dade PFA-10023 03 01 Partec CA-II23 03 02 Partec PAS-II21 01 01 Perkin-Elmer Lambda 1121 01 01 Perkin-Elmer Lambda 1221 01 01 Perkin-Elmer Lambda 1422 03 02 Pharmacia UniCAP22 03 02 Radim BRIO21 02 01 Radiometer ABL 521 02 01 Radiometer ABL 3021 02 01 Radiometer ABL 30021 02 01 Radiometer ABL 33021 02 01 Radiometer ABL 50021 02 01 Radiometer ABL 51021 02 01 Radiometer ABL 52021 02 02 Radiometer ABL 421 02 02 Radiometer ABL 50521 02 02 Radiometer ABL 62021 02 04 Radiometer ABL 62021 02 07 Radiometer OSM 324 01 02 Radiometer Sensititre21 01 01 Riele PMC 200021 01 01 Riele PM 21021 01 01 Riele PM 31021 01 31 Roche COBAS Ready (=SPOTCHEM)

21 01 41 Roche COBAS BIO21 01 41 Roche COBAS MIRA21 01 41 Roche COBAS MIRA S21 01 41 Roche COBAS MIRA PLUS21 01 41 Roche COBAS FARA21 01 41 Roche COBAS FARA II21 01 43 Roche COBAS INTEGRA22 03 02 Roche COBAS EIA System22 03 03 Roche COBAS CORE22 03 03 Roche COBAS CORE II22 03 05 Roche COBAS Amplicor 23 02 02 Roche COBAS MICROS 23 02 02 Roche COBAS MINOS ST23 02 02 Roche COBAS MINOS STE

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name23 02 02 Roche COBAS MINOS STX23 02 02 Roche COBAS MINOS STEX23 02 02 Roche COBAS MINOS VET23 02 03 Roche COBAS HELIOS LMG23 02 03 Roche COBAS HELIOS 5 Diff.23 02 04 Roche COBAS ARGOS LMG23 02 04 Roche COBAS ARGOS 5 Diff.23 02 04 Roche COBAS VEGA23 04 01 Roche Fibrometer22 03 03 Rosys Plato 130022 03 04 Rosys Plato 330022 02 02 Sanofi Diagnostics Pasteur QM 30022 03 01 Sanofi Diagnostics Pasteur LP 40022 03 03 Sanofi Diagnostics Pasteur Access22 03 04 Sanofi Diagnostics Pasteur AMS/LP 40022 03 04 Sanofi Diagnostics Pasteur Sonata24 01 03 Sanofi Diagnostics Pasteur Bio Argos26 02 02 Sanofi Diagnostics Pasteur AMSS23 02 02 SEAC GENIUS21 03 01 Sebia NN21 03 02 Sebia NN21 03 03 Sebia HYDRASYS22 03 03 Sorin ETI System22 03 04 Sorin Omni System23 04 01 Stago STA 223 04 01 Stago STA 423 04 01 Stago STA 823 04 01 Stago STA 88823 04 03 Stratec Stracomat23 02 01 Sysmex F-52023 02 01 Sysmex F-82023 02 02 Sysmex K-80023 02 02 Sysmex K-100023 02 03 Sysmex NE-150023 02 03 Sysmex K-450023 02 04 Sysmex SF-300023 02 04 Sysmex SE-900023 02 04 Sysmex NE-800023 02 11 Sysmex R-300023 03 01 Sysmex R-2000/300024 01 04 Sysmex UF-10023 04 03 Sysmex / Dade CA-100023 04 03 Sysmex / Dade CA-500023 04 03 Sysmex / Dade CA-600026 02 02 Tecan GENESIS RSP 20022 03 02 Tosoh AIA 60022 03 03 Tosoh AIA 120021 01 01 Unicam PU 861021 01 01 Unicam PU 862021 01 01 Vitatron IFP21 01 01 Vitatron ISP21 01 41 Wako 20R21 05 04 Wako NN21 01 42 Wako 30R

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name22 03 02 Wallac / Pharmacia Delfia22 03 03 Wallac / Pharmacia AutoDELFIA21 01 11 Yellow Springs YSI21 05 04 Yeong Deong NN

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name

Alphabetical Order by Instrument Name

21 01 01 Gilford 10323 02 01 Biochem Immunosystems 13023 02 01 Biochem Immunosystems 15023 02 01 Biochem Immunosystems 17021 01 01 Gilford 20323 02 01 Biochem Immunosystems 750023 02 01 Biochem Immunosystems 800023 02 02 Biochem Immunosystems 900021 01 41 Wako 20R21 01 42 Wako 30R23 02 02 Biochem Immunosystems 9100 +23 02 02 Biochem Immunosystems 9118 +23 02 02 Biochem Immunosystems 9120 +21 01 41 Abbott ABA 100 / 20021 02 01 Radiometer ABL 3021 02 01 Radiometer ABL 30021 02 01 Radiometer ABL 33021 02 02 Radiometer ABL 421 02 01 Radiometer ABL 521 02 01 Radiometer ABL 50021 02 02 Radiometer ABL 50521 02 01 Radiometer ABL 51021 02 01 Radiometer ABL 52021 02 02 Radiometer ABL 62021 02 04 Radiometer ABL 62023 02 01 Kone AC 90023 02 01 Kone AC 92023 02 02 Kone AC 97022 03 02 Dade (Dupont) ACA III22 03 02 Dade (Dupont) ACA STAR22 03 02 Dade (Dupont) ACA SX22 03 02 Dade (Dupont) ACA V22 03 03 Sanofi Diagnostics Pasteur Access23 04 02 Instrument. Lab. (IL) ACL 10023 04 03 Instrument. Lab. (IL) ACL 100023 04 02 Instrument. Lab. (IL) ACL 20023 04 03 Instrument. Lab. (IL) ACL 200023 04 02 Instrument. Lab. (IL) ACL 30023 04 03 Instrument. Lab. (IL) ACL 300023 04 03 Instrument. Lab. (IL) ACL 3000p23 04 03 Instrument. Lab. (IL) ACL 600023 04 03 Instrument. Lab. (IL) ACL Futura21 01 41 Eppendorf ACP 504022 03 03 Chiron (Ciba Corning) ACS 18022 03 03 Chiron (Ciba Corning) ACS 180 PLUS22 03 02 Abbott ADx22 03 03 Tosoh AIA 120022 03 02 Tosoh AIA 60024 01 02 BioMerieux Aladin22 03 02 Ortho Diag.Syst. (J&J) Amerlite22 03 03 Ortho Diag.Syst. (J&J) Amerlite PC22 03 04 Sanofi Diagnostics Pasteur AMS/LP 400

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name26 02 02 Sanofi Diagnostics Pasteur AMSS21 03 02 Beckman APPRAISE22 02 02 Beckman Array 2.022 02 02 Beckman Array 36021 01 41 Beckman AS 4 / AS 824 01 02 BioMerieux ATB Expression21 01 44 Olympus AU 100021 01 41 Olympus AU 20021 01 44 Olympus AU 5000 Series21 01 42 Olympus AU 51021 01 44 Olympus AU 5200 Series21 01 42 Olympus AU 56021 01 43 Olympus AU 60021 01 44 Olympus AU 800 22 03 02 Organon Teknika Auraflex22 03 01 Ortho Diagnostic Systems Auto Reader 322 03 03 Wallac / Pharmacia AutoDELFIA24 01 02 Dade Autoscan 4 24 01 02 Dade Autosceptor21 02 07 AVL AVL 91221 02 01 AVL AVL 94521 02 01 AVL AVL 99021 02 01 AVL AVL 99522 03 01 BioMerieux Axia 2 Reader22 03 01 BioMerieux Axia Microreader21 01 43 Bayer AXON22 03 03 Abbott AxSYM24 01 04 BioMerieux Bact-T-Screen 200024 01 03 Organon Teknika BacT/Alert 12024 01 03 Organon Teknika BacT/Alert 24024 01 03 Becton Dickinson Bactec 460 Tb24 01 03 Becton Dickinson Bactec 66024 01 03 Becton Dickinson Bactec 73024 01 03 Becton Dickinson Bactec 86024 01 03 Becton Dickinson Bactec 9000 MB24 01 03 Becton Dickinson Bactec 905024 01 03 Becton Dickinson Bactec 912024 01 03 Becton Dickinson Bactec 924023 04 03 Behring BCS23 04 03 Behring BCT22 03 02 Behring BEP II22 03 04 Behring BEP III22 03 04 Behring BEP XL (Micro Trak XL)22 03 01 Behring Berilux 25022 03 02 Behring BeriLux 40023 04 03 Behring BFA24 01 03 Sanofi Diagnostics Pasteur Bio Argos24 01 04 Lumac Biocounter M230024 01 04 Lumac Biocounter M300026 02 02 Beckman BIOMEK 200023 04 03 Chiron (Ciba Corning) Biotrack 51222 02 02 Behring BN 10022 02 02 Behring BN II22 02 02 Behring BNA

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name23 05 01 Menarini BOSS22 03 02 Radim BRIO21 01 01 BioSystems BTS 30221 01 01 BioSystems BTS 30521 01 01 BioSystems BTS 31023 04 03 Sysmex / Dade CA-100023 04 03 Sysmex / Dade CA-500023 04 03 Sysmex / Dade CA-600023 03 01 Partec CA-II22 02 01 Nycomed Card Reader21 03 03 Helena Cardio REP23 04 02 Helena Cascade 48023 04 01 Helena Cascade M-423 02 01 Coulter CBC-521 02 01 Chiron (Ciba Corning) CCD 23821 02 01 Chiron (Ciba Corning) CCD 24821 02 07 Chiron (Ciba Corning) CCD 27021 02 01 Chiron (Ciba Corning) CCD 27821 02 01 Chiron (Ciba Corning) CCD 28021 02 02 Chiron (Ciba Corning) CCD 34821 02 07 Chiron (Ciba Corning) CCD 81521 02 01 Chiron (Ciba Corning) CCD 84021 02 04 Chiron (Ciba Corning) CCD 84521 02 02 Chiron (Ciba Corning) CCD 85021 02 04 Chiron (Ciba Corning) CCD 85521 02 02 Chiron (Ciba Corning) CCD 86021 02 04 Chiron (Ciba Corning) CCD 86521 02 06 Chiron (Ciba Corning) CCD 86523 02 02 Abbott CELL-DYN 130023 02 02 Abbott CELL-DYN 140023 02 02 Abbott CELL-DYN 160023 02 02 Abbott CELL-DYN 170023 02 03 Abbott CELL-DYN 200023 02 01 Abbott CELL-DYN 30023 02 04 Abbott CELL-DYN 300023 02 04 Abbott CELL-DYN 350023 02 01 Abbott CELL-DYN 40023 02 04 Abbott CELL-DYN 400023 02 01 Abbott CELL-DYN 50023 02 01 Abbott CELL-DYN 61023 02 01 Abbott CELL-DYN 70023 02 01 Abbott CELL-DYN 80023 02 01 Abbott CELL-DYN 90023 02 01 Nihon Kohden Celltak MEK-510023 02 02 Nihon Kohden Celltak-Auto21 01 44 Bayer CHEM 123 04 01 Behring Chromotimer22 03 03 CIS-Bio Cispack 420023 04 01 Behnk CL423 04 01 Behnk CL821 01 41 Menarini Classic/Artax21 01 32 Beckman Clinical System 70021 05 02 Bayer Clinitek 10021 05 03 Bayer Clinitek 200

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name21 05 03 Bayer Clinitek 200 +21 05 02 Bayer Clinitek 5021 05 04 Bayer Clinitek Atlas23 04 01 Labor COA Data 1000-300023 04 01 Labor COA Screener23 04 01 Labor COA System23 04 03 Organon Teknika Coag-A-Mate MDA23 04 03 Organon Teknika Coag-A-Mate MTX23 04 02 Organon Teknika Coag-A-Mate RA 423 04 02 Organon Teknika Coag-A-Mate X223 04 01 Organon Teknika Coag-a-Mate XM23 04 02 Boehringer Mannheim / Stago Coasys 11023 04 01 LRE Coatron F23 04 01 LRE Coatron F II23 04 02 LRE Coatron Fx23 04 02 LRE Coatron Jr.22 03 05 Roche COBAS Amplicor 23 02 04 Roche COBAS ARGOS 5 Diff.23 02 04 Roche COBAS ARGOS LMG21 01 41 Roche COBAS BIO22 03 03 Roche COBAS CORE22 03 03 Roche COBAS CORE II22 03 02 Roche COBAS EIA System21 01 41 Roche COBAS FARA21 01 41 Roche COBAS FARA II23 02 03 Roche COBAS HELIOS 5 Diff.23 02 03 Roche COBAS HELIOS LMG21 01 43 Roche COBAS INTEGRA23 02 02 Roche COBAS MICROS 23 02 02 Roche COBAS MINOS ST23 02 02 Roche COBAS MINOS STE 23 02 02 Roche COBAS MINOS STEX23 02 02 Roche COBAS MINOS STX23 02 02 Roche COBAS MINOS VET21 01 41 Roche COBAS MIRA21 01 41 Roche COBAS MIRA PLUS21 01 41 Roche COBAS MIRA S21 01 31 Roche COBAS Ready (=SPOTCHEM)

23 02 04 Roche COBAS VEGA22 03 04 Abbott Commander / FPC21 02 01 AVL Compact 121 02 01 AVL Compact 221 03 03 Helena Concept 200024 01 04 Coral Biotechnology Coral Wave 12021 01 19 Beckman Creatinine-Analyzer 221 03 03 Eppendorf (JOKOO) CTE 100021 03 03 Eppendorf (JOKOO) CTE 500023 03 01 Ortho Diag.Syst. (J&J) Cytoron Absolute21 01 43 Bayer DAX 2421 01 43 Bayer DAX 4821 01 44 Bayer DAX 7221 01 44 Bayer DAX 9621 01 12 Bayer DCA 200022 03 02 Wallac / Pharmacia Delfia

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name21 01 42 Kone Delta21 01 12 Bio-Rad DIAMAT22 03 04 Murex DIAS System21 01 41 Dade (Dupont) Dimension 38021 01 43 Dade (Dupont) Dimension 76021 01 43 Dade (Dupont) Dimension AR21 01 41 Dade (Dupont) Dimension ES21 01 43 Dade (Dupont) Dimension XL22 02 02 Bayer DPA-121 01 01 Beckman DU 521 01 42 Kone Dynamic21 01 52 Beckman E2A21 01 41 Eppendorf EASY21 01 31 Merck EASY ST21 01 11 Eppendorf EBIO Compact21 01 29 Eppendorf EBIO Plus22 03 01 Merck Eclair21 01 01 Merck Eclipse21 01 01 Merck Eclipse Plus21 01 01 Eppendorf ECOM 612222 03 01 Behring ECOM 6123 D22 03 01 Eppendorf ECOM 6123 D21 01 01 Eppendorf ECOM 6124 F21 01 41 Eppendorf ELAN22 03 02 Boehringer Mannheim ElecSys 101022 03 03 Boehringer Mannheim ElecSys 201023 04 03 Ortho Diagnostic Systems (MLA) Electra 1000 C23 04 03 Ortho Diagnostic Systems (MLA) Electra 1400 C23 04 03 Ortho Diagnostic Systems (MLA) Electra 1600 C23 04 01 Ortho Diagnostic Systems (MLA) Electra 70023 04 02 Ortho Diagnostic Systems (MLA) Electra 80023 04 02 Ortho Diagnostic Systems (MLA) Electra 90023 04 02 Ortho Diagnostic Systems (MLA) Electra 900 C22 03 01 Behring Elisa-Photometer22 03 01 Behring Elisa-Reader 30122 03 01 Behring Elisa-Reader 31121 01 53 Beckman ELISE22 03 04 BIO-TEK ELx80821 01 32 Eppendorf EPAC 614023 03 02 Coulter Epics Elite23 03 01 Coulter Epics Profile II21 01 41 Eppendorf EPOS21 01 42 Abbott EPx21 01 42 Eppendorf ERIS22 03 01 Boehringer Mannheim ES 1122 03 01 Boehringer Mannheim ES 2222 03 02 Boehringer Mannheim ES 30022 03 01 Boehringer Mannheim ES 3322 03 03 Boehringer Mannheim ES 60022 03 03 Boehringer Mannheim ES 70024 01 03 Difco ESP21 01 42 Eppendorf ETEC22 03 03 Sorin ETI System22 03 02 Behring ETS Plus

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name21 01 41 Chiron (Ciba Corning) EXPRESS23 02 01 Sysmex F-52023 02 01 Sysmex F-82023 03 01 Becton-Dickinson FACSCalibur23 03 01 Becton-Dickinson FACScan23 03 01 Becton-Dickinson FACSCount23 03 02 Becton-Dickinson FACSort23 03 02 Becton-Dickinson FACStarPlus

23 03 01 Becton-Dickinson FACStrak23 03 02 Becton-Dickinson FACSVantage 21 01 42 Menarini Falcor 30021 01 42 Menarini Falcor 60021 03 01 COSMO FED 320022 02 01 Bio-Whittaker Fiax23 04 01 Behring Fibrintimer 1023 04 01 Behring Fibrintimer II23 04 01 Roche Fibrometer23 04 01 Labsystems FP 90023 04 01 Labsystems FP 91021 03 02 Olympus Fractoscan21 03 02 Olympus Fractoscan Junior21 02 02 Instrument. Lab. (IL) GEM 6+21 02 02 Instrument. Lab. (IL) GEM PREMIER21 02 02 Instrument. Lab. (IL) GEM PREMIER PLUS21 02 02 Instrument. Lab. (IL) GEM STAT26 02 02 Tecan GENESIS RSP 20023 02 02 SEAC GENIUS21 01 11 Beckman Glucose-Analyzer 221 01 12 Chiron (Ciba Corning) Glycomat23 02 04 Bayer H 1 E23 02 04 Bayer H 223 02 04 Bayer H 3 RTC23 02 04 Bayer H 3 RTX23 02 03 Bayer H123 02 02 Bayer H1JR21 01 12 Menarini HA 811021 01 12 Menarini HA 812121 01 12 Menarini HA 814023 04 03 BioMerieux Hemolab21 01 44 Boehringer Mannheim HIT 73721 01 44 Boehringer Mannheim HIT 747 Series21 01 12 Merck Hitachi L 900021 01 41 Boehringer Mannheim Hitachi 70421 01 41 Boehringer Mannheim Hitachi 70521 01 43 Boehringer Mannheim Hitachi 71721 01 41 Boehringer Mannheim Hitachi 90421 01 42 Boehringer Mannheim Hitachi 91121 01 43 Boehringer Mannheim Hitachi 91721 03 03 Olympus HITE SYSTEM 31021 03 03 Olympus HITE SYSTEM 32021 03 03 Olympus HITE SYSTEM 62021 03 03 Menarini HS 721 03 03 Sebia HYDRASYS22 02 01 Beckman ICS

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name21 01 01 Vitatron IFP21 02 01 Instrument. Lab. (IL) IL 130421 02 01 Instrument. Lab. (IL) IL 130621 02 01 Instrument. Lab. (IL) IL 1312 21 02 02 Instrument. Lab. (IL) IL 1400 21 02 02 Instrument. Lab. (IL) IL 140521 02 01 Instrument. Lab. (IL) IL 142021 02 02 Instrument. Lab. (IL) IL 143021 02 01 Instrument. Lab. (IL) IL 161021 02 01 Instrument. Lab. (IL) IL 162021 02 02 Instrument. Lab. (IL) IL 163021 02 02 Instrument. Lab. (IL) IL 164021 02 02 Instrument. Lab. (IL) IL 165021 02 07 Instrument. Lab. (IL) IL 48221 01 52 Instrument. Lab. (IL) IL 614, 644, 65421 02 07 Instrument. Lab. (IL) IL 68221 01 51 Instrument. Lab. (IL) IL 94321 02 01 Instrument. Lab. (IL) IL BG321 01 44 Instrument. Lab. (IL) ILab 180021 01 43 Instrument. Lab. (IL) ILab 90022 02 02 Beckman IMMAGE22 03 02 DPC Immulite22 03 03 Bayer Immuno-I22 03 02 Abbott IMx / IMx Select21 02 02 Diametrics IRMA21 01 01 Vitatron ISP23 02 03 Coulter JR23 02 03 Coulter JS23 02 02 Sysmex K-100023 02 03 Sysmex K-450023 02 02 Sysmex K-80023 04 01 Amelung KC 1023 04 01 Amelung KC 10A23 04 01 Amelung KC 423 04 03 Amelung KC 4022 02 02 Boehringer Mannheim KeySys23 04 02 Ortho Diagnostic Systems (MLA) Koagulab 16-60523 04 01 Ortho Diagnostic Systems (MLA) Koagulab CTS21 01 31 Cholestech L.D.X22 03 03 Biochem Immunosystems Labotec21 01 01 Perkin-Elmer Lambda 1121 01 01 Perkin-Elmer Lambda 1221 01 01 Perkin-Elmer Lambda 1422 03 05 Abbott LCx22 03 02 Byk-Sangtek LIA-mat S 30022 03 01 Merck LM-821 01 01 Lange (Dr. Lange) LP 121 01 01 Lange (Dr. Lange) LP 321 01 01 Lange (Dr. Lange) LP 40022 03 01 Sanofi Diagnostics Pasteur LP 40021 01 01 Lange (Dr. Lange) LP 50021 01 01 Lange (Dr. Lange) LP 6A23 02 01 Coulter M43023 02 01 Coulter M530

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name22 03 03 Merck (Biotrol) MAGIA 700022 03 03 Merck (Biotrol) MAGIA 800022 03 01 Chiron (Ciba Corning) Magic Lite I22 03 02 Chiron (Ciba Corning) Magic Lite II22 03 02 Chiron (Ciba Corning) Magic Lite II+22 03 02 Chiron (Ciba Corning) Magic Lite SQ Allergy System

24 01 02 Mast Mastascan22 03 01 Abbott Matrix22 03 04 DPC / Biermann MAX23 02 04 Coulter MAXM23 04 02 Biodata MCA 11023 02 02 Coulter MD 1623 02 01 Coulter MD 823 02 02 Coulter MD II21 01 43 Merck MEGA22 03 04 Murex MIAS System22 03 01 Murex Micro ELISA MRX Reader22 03 01 Murex Micro ELISA Reader 700022 03 01 Organon Teknika Microelisa Reader 10022 03 01 Organon Teknika Microelisa System22 03 04 Hamilton Microlab F.A.M.E.24 01 02 Dade Microscan Walkaway 4024 01 02 Dade Microscan Walkaway 9622 03 01 Behring Microtrack Reader SE System

21 05 03 Boehringer Mannheim Miditron21 05 03 Boehringer Mannheim Miditron Junior22 03 02 DPC Milenia Max22 03 02 BioMerieux Mini-VIDAS21 05 01 Menarini MiniAution21 01 01 Lange (Dr. Lange) Miniphotometer 821 05 02 Boehringer Mannheim Minitron22 03 04 Merck MIOS21 01 01 Bayer ML 121 01 01 Bayer ML221 01 01 Bayer ML321 01 01 Beckman Model 4221 01 41 Instrument. Lab. (IL) Monarch 100021 01 42 Instrument. Lab. (IL) Monarch 200021 01 42 Instrument. Lab. (IL) Monarch PLUS22 03 04 Organon Teknika MPP 300022 03 05 Organon Teknika NASBA QR System23 02 03 Sysmex NE-150023 02 04 Sysmex NE-800021 03 01 Helena NN21 03 02 Helena NN21 03 01 Sebia NN21 03 02 Sebia NN21 05 04 Wako NN21 05 04 Yeong Deong NN21 01 42 Nova Nucleus21 02 04 AVL OMNI22 03 04 Sorin Omni System23 02 03 Coulter Onyx21 01 42 Bayer OPERA

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name21 02 01 AVL OPTI 121 01 42 Coulter Optichem 50021 01 42 Kone Optima23 04 01 BioMerieux Option 2-822 03 02 Behring OPUS22 03 03 Behring OPUS Magnum22 03 02 Behring OPUS PLUS21 02 07 Radiometer OSM 323 04 04 Biodata PAP 421 03 01 Beckman PARAGON21 03 03 Beckman PARAGON CZE 200021 01 43 Dade (Dupont) Paramax-RX23 03 02 Partec PAS-II24 01 02 Difco Pasco21 01 01 Eppendorf PCP 612121 01 43 American Monitor Perspective/Excel23 04 04 Ortho Diagnostic Systems / Dade PFA-10021 01 01 Boehringer Mannheim Photometer 401021 01 01 Boehringer Mannheim Photometer 402022 03 02 Hybritech Photon Era22 03 01 Hybritech Photon II23 05 01 Olympus PK 710023 05 01 Olympus PK 720023 05 01 Olympus PK 8022 03 03 Rosys Plato 130022 03 04 Rosys Plato 330021 01 01 Riele PM 21021 01 01 Riele PM 31021 01 01 Riele PMC 200026 02 02 Abbott PPC26 02 09 Boehringer Mannheim PPV21 03 03 Helena PRINCE-CE22 03 04 Abbott PRISM22 03 05 Becton Dickinson ProbeTec21 01 41 Kone Progress21 01 41 Kone Progress Plus21 01 01 Unicam PU 861021 01 01 Unicam PU 862023 02 01 Becton-Dickinson QBC Autoread23 02 01 Becton-Dickinson QBC I23 02 01 Becton-Dickinson QBC II22 02 02 Sanofi Diagnostics Pasteur QM 30022 03 01 Abbott Quantum22 03 01 Abbott Quantum II22 03 03 Kone Quartus23 05 01 Lifescreen QUASAR 24023 05 01 Lifescreen QUASAR 40024 01 04 Difco Questor22 02 01 Orion Diagnostica QuikRead 323 03 01 Sysmex R-2000/300023 02 11 Sysmex R-300021 01 41 Bayer RA 100021 01 41 Bayer RA 5021 01 41 Bayer RA 500

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name21 01 41 Bayer RA XT21 01 42 Bayer RA200022 03 04 Bio-Rad Radius24 01 02 Mast Radius24 01 04 Orbec Ramus21 05 03 Behring RAPIMAT21 01 31 Boehringer Mannheim Reflotron21 01 31 Boehringer Mannheim Reflotron Sprint21 03 03 Helena REP23 02 02 Coulter S77023 02 03 Coulter S88024 01 02 Becton Dickinson Sceptor24 01 02 Becton Dickinson Sceptorpette23 02 04 Sysmex SE-900021 01 41 Merck Selectra24 01 02 Radiometer Sensititre24 01 03 Difco Sentinel21 01 31 Bayer Seralyzer22 03 01 Biochem Immunosystems Serazyme I22 03 01 Biochem Immunosystems Serazyme II23 02 04 Sysmex SF-300022 03 02 Behring Solaris22 03 04 Sanofi Diagnostics Pasteur Sonata21 01 41 Kone Specific21 01 41 Kone Specific Supra21 01 01 Milton-Roy Spectronic 1001+ 21 01 01 Milton-Roy Spectronic 110121 01 01 Milton-Roy Spectronic 120121 01 01 Milton-Roy Spectronic 20 / 20 D21 01 01 Milton-Roy Spectronic 21 DV 21 01 01 Milton-Roy Spectronic 21 MV21 01 01 Milton-Roy Spectronic 21 UVD21 01 01 Milton-Roy Spectronic 300021 01 01 Milton-Roy Spectronic 30121 01 01 Milton-Roy Spectronic 40121 01 01 Milton-Roy Spectronic 50121 01 01 Milton-Roy Spectronic 60121 01 41 Abbott Spectrum21 01 31 Eppendorf SPOTCHEM21 01 31 Menarini SPOTCHEM22 03 02 Biochem Immunosystems SR 123 02 04 Coulter ST23 04 03 Boehringer Mannheim / Stago STA23 04 01 Stago STA 223 04 01 Stago STA 423 04 01 Stago STA 823 04 01 Stago STA 88823 04 03 Boehringer Mannheim / Stago STA Compact21 02 01 Nova Stat Profile 321 02 02 Nova Biomedical Stat Profile Plus 9,1021 02 02 Nova Biomedical Stat Profile1,2,4,5,723 02 04 Coulter STKR23 02 04 Coulter STKS23 04 03 Stratec Stracomat

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name22 03 02 Dade Stratus I22 03 02 Dade Stratus II24 01 02 I2R STRSCAN22 03 04 Ortho Diagnostic Systems Summit26 02 02 Ortho Diag.Syst. (J&J) Summit Plus 226 02 02 Ortho Diag.Syst. (J&J) Summit Processor21 05 04 Menarini SuperAution21 05 04 Boehringer Mannheim Supertron21 01 42 Beckman Synchron CX 3 DELTA21 01 42 Beckman Synchron CX 421 01 42 Beckman Synchron CX 4 DELTA21 01 42 Beckman Synchron CX 521 01 42 Beckman Synchron CX 5 DELTA21 01 43 Beckman Synchron CX 721 01 43 Beckman Synchron CX 7 DELTA21 01 41 Beckman Synchron CX321 02 04 Instrument. Lab. (IL) Synthesis 25 /3522 03 01 Dynatech System 500022 03 04 Dynatech System 700023 02 02 Coulter T54023 02 02 Coulter T66023 02 03 Coulter T89022 03 02 Abbott TDx / TDxFLx22 03 03 Organon Teknika Tektime23 04 03 Behnk Thrombolyser23 04 01 Nycomed Thrombotrack24 01 02 Dade Touchscan 22 02 01 Behring TurbiTimer22 02 01 Orion Diagnostica Turbox24 01 04 Sysmex UF-10021 01 42 Kone Ultra 22 03 02 Pharmacia UniCAP24 01 02 BioMerieux Uniscept21 01 19 Beckman Urea-Analyzer 221 05 02 Boehringer Mannheim Urilux21 05 02 IMACO URIMAC24 01 04 BioMerieux URIMAT21 05 03 Boehringer Mannheim Urotron RL 921 01 12 Bio-Rad VARIANT22 03 02 BioMerieux VIDAS24 01 02 Biokit Videobact21 01 31 Abbott Vision24 01 03 BioMerieux Vital 1200 24 01 03 BioMerieux Vital 20024 01 02 BioMerieux Vitek 12024 01 02 BioMerieux Vitek 24024 01 02 BioMerieux Vitek 3224 01 02 BioMerieux Vitek 6024 01 02 BioMerieux Vitek Junior22 03 03 Ortho Diag.Syst. (J&J) VITROS ECI21 01 42 Ortho Diag.Syst. (J&J) VITROS(Ektachem) 25021 01 42 Ortho Diag.Syst. (J&J) VITROS(Ektachem) 50021 01 43 Ortho Diag.Syst. (J&J) VITROS(Ektachem) 750 XRC21 01 43 Ortho Diag.Syst. (J&J) VITROS(Ektachem) 950 IRC

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EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS

EDMA CODE Company Instrument-Name21 01 31 Ortho Diag.Syst. (J&J) VITROS(Ektachem) DT 6021 01 41 Abbott VP21 01 11 Yellow Springs YSI23 02 01 Coulter ZM

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