Edma Classification Instrument

EDMAEDMA CODE

IVD PRODUCT CLASSIFICATIONCompany

INSTRUMENTS

Instrument-Name

Table of ContentsPage

Diagram: Instrument Classification Instrument Classification Overview Instrument Grouping - Clinical Chemistry Instruments - Immunochemistry Instruments - Haematology Instruments - Microbiology Instruments - Other Clinical Instruments - Data Management Systems Alphabetical Order by Company

Level 1 - 2 Level 1 - 3

2 3 6 6 14 17 22 23 23 24 36

Alphabetical Order by Instrument Name

EDMA - MRWP 19.02.2008 *WP* EDMA_Classification_Instrument_97.xls Instruments Page 1 of 47

Revision 3 - April 1997

EDMAEDMA CODE


INSTRUMENTS

Instrument-Name

Diagram

Instrument Classification Level 1 - 2

2

INSTRUMENTS

Level 1CATEGORIES

21CLINICAL CHEMISTRY INSTRUMENTS

22IMMUNOCHEMISTRY INSTRUMENTS

23HAEMATOLOGY INSTRUMENTS

24MICROBIOLOGY INSTRUMENTS

26OTHER CLINICAL INSTRUMENTS

27DATA MANAGEMENT SYSTEMS

21 Chemistry Analyser

22 01 RIA Equipment

23 01 Haemoglobin Analyser 23 02 Blood Cell Counter

24 01 Bacteriology Instruments 24 09 Other Microbiology Instruments

26 01 Clinical Centrifuges

27 01 DMS Hardware 27 02 DMS Software / Consumables

21 02 Blood Gas Analyser 21 03 Electrophoresis Equipment 21 04 Chromatography Equipment 21 05 Urine Analyser 21 06 Self Testing Equipment 21 09 Other Clin.Chem. Instruments

22 02 Protein Analyser 22 03 Immunoassay Analyser 22 09 Other Immunochem. Instruments

26 02 Sample Processors

Level 2 Groups

23 03 Flow Cytometer 23 04 Coagulation Systems 23 05 Blood Grouping Instruments 23 06 Histology Equipment 23 09 Other Haematology Instruments

26 03 Washers 26 09 Other Other Clinical Instruments

Level 3 ==> see following pages Subgroups



EDMAEDMA CODE


INSTRUMENTS

Instrument-Name

Instrument Classification Overview2 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 01 01 01 01 01 01 01 01 01 01 01 01 01 01 01 02 02 02 02 02 02 02 02 01 11 12 19 29 31 32 41 42 43 44 51 52 53

Level 1 - 3

Page

INSTRUMENTSCLINICAL CHEMISTRY INSTRUMENTS Chemistry AnalyserManual Photometer and Spectrophotometer Dedicated Glucose Systems Dedicated Glycated Haemoglobin /HbA1 Systems Other Dedicated Single-Parameter CC Systems Dedicated Multi-Parameter CC Systems Small Manual and Semi-automated CC Systems Semi-automated CC Analyser Small Automated CC Analyser Medium Automated CC Analyser Large Automated CC Analyser Extra large Automated CC Analyser Electrolyte - Flame photometer Electrolyte/ISE only Electrolyte/ISE and other parameter

6

7

8 9

10

Blood Gas Analyser01 02 03 04 06 07 09Blood Gas (p02 / pC02 + pH) Blood Gas and Electrolytes Blood Gas and CO-Oximeter Blood Gas, Electrolytes and CO-Oximeter Blood Gas, Electrolytes, CO-Oximeter and Other Parameters CO-Oximeter Other Blood Gas Instruments

11

03 03 01 03 02 03 03

Electrophoresis EquipmentManual Electrophoresis Densitometers Automated integrated Electrophoresis Systems

12

21 04 21 21 21 21 21 21 21 21 21 21 05 05 05 05 05 06 06 06 06 06

Chromatography Equipment Urine Analyser01 02 03 04 01 02 03 11Manual Urine Analyzer Small Automated Urine Analyzer Medium Automated Urine Analyzer Large Automated Urine Analyzer

13

Self Testing Equipment (Clin.Chem.)Blood Glucose Meter Cholesterol Meter Lactate Meter Multiparameter CC Meter

21 09

Other Clinical Chemistry Instruments



EDMAEDMA CODE 22 22 01 22 01 01 22 02 22 02 01 22 02 02 22 22 22 22 22 22 03 03 03 03 03 03


INSTRUMENTSPage

Instrument-Name

IMMUNOCHEMISTRY INSTRUMENTS RIA EquipmentRIA Counter

14

Protein AnalyserSmall Protein Analyser Large Protein Analyser

Immunoassay Analyser01 02 03 04 05Manual I.A. Instruments / Readers Semi-automated I.A. Systems Automated I.A. Systems Batch / High throughput I.A. Systems Nucleic Acid Processors

15 16

22 09 23 23 01 23 01 01 23 23 23 23 23 23 02 02 02 02 02 02

Other Immunochemistry Instruments HAEMATOLOGY INSTRUMENTS Haemoglobin AnalyserDedicated Total Haemoglobin Analyser

17

Blood Cell Counter01 02 03 04 11No differential Blood Cell Counter 2 / 3 part differential Blood Cell Counter 5 part differential low / medium end Blood Cell Counter 5 part differential high end Blood Cell Counter Dedicated Reticulocyte Analyser

18 19

23 03 23 03 01 23 03 02 23 23 23 23 23 23 04 04 04 04 04 04

Flow CytometerFlow Cytometer without Cell sorter Flow Cytometer with Cell sorter

Coagulation Systems01 02 03 04 05Manual Coagulation Instruments Semi-automated Coagulation Systems Fully-automated Coagulation Systems Aggregometer Selftesting Equipment (Coagulation)

20

21

23 05 23 05 01 23 06 23 06 01 23 06 02 23 09 23 09 01

Blood Grouping InstrumentsBlood Grouping Instruments

Histology Equipment (excl.microscopes)General Histology Instruments Mictrotomes

Other Haematology InstrumentsSediment rate Instruments



EDMAEDMA CODE 24 24 24 24 24 24 01 01 01 01 01


INSTRUMENTSPage

Instrument-Name

MICROBIOLOGY INSTRUMENTS Bacteriology Instruments01 02 03 04Plate pouring Instruments Susceptibility and / or ID-systems Blood Culture Systems Dedicated Urine Screening MB Instruments

22

23

24 09 26 26 01 26 26 26 26 26 26 26 26 26 26 02 02 02 02 02 02

Other Microbiology Instruments OTHER CLINICAL INSTRUMENTS Clinical Centrifuges Sample Processors01 02 03 04 09Clinical Chemistry Sample Processors Immuno Assays Sample Processors Haematology Sample Processors Microbiology Sample Processors Multiple Purpose Sample Processors

03 03 02 03 03 03 09

WashersImmuno Assays Washers Haematology Washers Other Washers

26 09 27 27 01 27 02

Other Other Clinical Instruments DATA MANAGEMENT SYSTEMS Data Management Hardware Data Management Software/Consumables



EDMAEDMA CODE


INSTRUMENTS

Instrument-Name

Instrument Grouping2 21 21 01 21 01 01

INSTRUMENTS CLINICAL CHEMISTRY INSTRUMENTS Chemistry AnalyserManual Photometer and SpectrophotometerBayer ML 1 ML2 ML3 Model 42 DU 5 UV-VIS Jr UV-VIS 1 UV-VIS 2 VISUAL BTS 302 BTS 305 BTS 310 Photometer 4010 Photometer 4020 Photometer 5010 PCP 6121 ECOM 6122 ECOM 6124 F 103 203 ISIS LP 1 LP 3 LP 6A LP 400 LP 500 Miniphotometer 8 Miniphotometer 20 Eclipse Eclipse Plus Spectronic 1001+ Spectronic 1101 Spectronic 1201 Spectronic 20 / 20 D Spectronic 21 DV Spectronic 21 MV Spectronic 21 UVD Spectronic 3000 Spectronic 301 Spectronic 401 Spectronic 501 Spectronic 601 Lambda 11 Lambda 12 Lambda 14 PMC 2000 PM 210 PM 310 PU 8610 PU 8620 IFP ISP

Beckman BioMrieux

BioSystems

Boehringer Mannheim

Eppendorf

Gilford

HycelLange (Dr. Lange)

Merck Milton-Roy

Perkin-Elmer

Riele

Unicam Vitatron



EDMAEDMA CODE 21 01 11

IVD PRODUCT CLASSIFICATIONCompany Dedicated Glucose Systems Beckman Eppendorf Radiometer Yellow Springs Dedicated Glycated Haemoglobin /HbA1 Systems ARKRAY KDK Bayer Bio-Rad

INSTRUMENTS

Instrument-Name

Glucose-Analyzer 2 EBIO Compact ABL System 625 YSI

21 01 12

Chiron Kontron Menarini

Merck

Hi-Auto A1c HA 8140 DCA 2000 DIAMAT DiaSTAT VARIANT Glycomat NN HA 8110 HA 8121 HA 8140 Hitachi L 9000

21 01 19

Other Dedicated Single-Parameter CC Systems Analox Instruments Beckman ElvilogosLM10 Creatinine-Analyzer 2 Urea-Analyzer 2 Bilirubinometer

21 01 29

Dedicated Multi-Parameter CC Systems Analox Instruments EppendorfP-GM7 micro-Stat EBIO Plus

21 01 31

Small Manual and Semi-automated CC Systems Abbott Bayer Boehringer Mannheim Cholestech Ortho Diag. Systems (J&J) Eppendorf Menarini Merck Roche

Vision Seralyzer Reflotron Reflotron Sprint L.D.X Vitros DT 60/Vitros DT60 SPOTCHEM SPOTCHEM EASY ST COBAS Ready (=SPOTCHEM)

21 01 32

Semi-automated CC Analyser Beckman BPC BioSED Eppendorf Clinical System 700 NN EPAC 6140




IVD PRODUCT CLASSIFICATIONCompany Small Automated CC Analyser Abbott

INSTRUMENTS

Instrument-Name

Bayer

Beckman Boehringer Mannheim

Chimica Dianostica Chiron Dade (Dupont) Diagnostic Testing Eppendorf

Hycel Instrumentation Laboratory Kone

Menarini Merck Olympus Roche

Schiaparelli Sigma Wako

ABA 100 / 200 VP Spectrum RA 50 RA 500 RA 1000 RA XT AS 4 / AS 8 Synchron CX3 Autolab Hitachi 704 Hitachi 705 Hitachi 902 Hitachi 904 Naxos EXPRESS Dimension 380 Dimension ES Piccolo ACP 5040 EASY EPOS ELAN LISA 200 LISA 300 Monarch 1000 Progress Progress Plus Specific Specific Supra Pro Classic/Artax Selectra AU 200 COBAS BIO COBAS MIRA COBAS MIRA S COBAS MIRA PLUS COBAS FARA COBAS FARA II ACE SD2000 20R




IVD PRODUCT CLASSIFICATIONCompany Medium Automated CC Analyser Abbott Bayer Beckman

INSTRUMENTS

Instrument-Name

Boehringer Mannheim Coulter Eppendorf Instrumentation Laboratory Kone

Hycel Menarini Nova Olympus Ortho Diag. Systems (J&J) Wako

EPx RA2000 OPERA Synchron CX 3 DELTA Synchron CX 4 Synchron CX 4 DELTA Synchron CX 5 Synchron CX 5 DELTA Hitachi 911 Optichem 500 ERIS ETEC Monarch PLUS Monarch 2000 Delta Dynamic Optima Ultra LISA 400 Falcor 300 Falcor 600 Nucleus AU 510 AU 560 Vitros 250 Vitros 500 30R

21 01 43

Large Automated CC Analyser American Monitor Bayer

Beckman Boehringer Mannheim Dade (Dupont)

Instrumentation Laboratory Merck Olympus Ortho Diag. Systems (J&J) Roche

Perspective/Excel AXON DAX 24 DAX 48 Synchron CX 7 / CX7 Delta Hitachi 717 Hitachi 917 Paramax-RX Dimension 760 Dimension AR Dimension XL ILab 900 MEGA AU 600 Vitros 750 XRC Vitros 950 IRC/Vitros 950 COBAS INTEGRA

21 01 44

Extra large Automated CC Analyser Bayer

Boehringer Mannheim Instrumentation Laboratory Olympus

CHEM 1 DAX 72 DAX 96 HIT 737 HIT 747 Series ILab 1800 AU 800 AU 1000 AU 5000 Series AU 5200 Series




IVD PRODUCT CLASSIFICATIONCompany Electrolyte - Flame photometer Hycel Instrumentation Laboratory

INSTRUMENTS

Instrument-Name

PHF 104 PHF 106 IL 943

21 01 52

Electrolyte/ISE only AVL Beckman Hycel Instrumentation Laboratory YSI9180 Electrolyte Analyser E2A EASYLYTE IL 614, 644, 654 EasyLyte

21 01 53 21 02 21 02 01

Electrolyte/ISE and other parameter Beckman

ELISE

Blood Gas AnalyserBlood Gas (p02 / pC02 + pH) AVLAVL 945 AVL 990 AVL 995 OPTI 1 Compact 1 Compact 2 CCD 238 CCD 248 CCD 278 CCD 280 CCD 840 i-STAT IL 1304 IL 1306 IL 1312 IL 1420 IL 1610 IL 1620 IL BG3 Stat Profile 3 ABL 5 ABL 30 ABL 300 ABL 330 ABL 500 ABL 510 ABL 520

Chiron

Hewlett Packard Instrumentation Laboratory

Nova Radiometer




IVD PRODUCT CLASSIFICATIONCompany Blood Gas and Electrolytes Chiron

INSTRUMENTS

Instrument-Name

Diametrics Instrumentation Laboratory

CCD 348 CCD 850 CCD 860 IRMA IL 1400 IL 1405 IL 1430 IL 1630 IL 1640 IL 1650 GEM Premier GEM STAT

GEM 6+ Nova BiomedicalGEM Premier Plus Stat Profile1,2,4,5,7 Stat Profile Plus 9,10 Stat Profile Ultra ABL 4 ABL 505 ABL 620 OMNI

Radiometer

AVL

21 02 03 21 02 04

Blood Gas and CO-Oximeter Blood Gas, Electrolytes and CO-Oximeter AVL Chiron Instrumentation Laboratory Radiometer

OMNI CCD 845 CCD 855 Synthesis 25 / 35 ABL 620

21 02 06

Blood Gas, Electrolytes, CO-Oximeter and Other Parameters CCD 865 Chiron Nova Stat Profile Ultra CO-Oximeter AVL Chiron Instrumentation Laboratory RadiometerAVL 912 CCD 270 CCD 815 IL 482 IL 682 OSM 3

21 02 07

21 02 08

Osmometer Gonotec Slamed Roebling Vitech Scientific WescorOsomat 030/030D Osomat 050 Osmometer 800 cl Micro-Osmometer Model 3900 Vapro

21 02 09

Sweat Analyzer WescorSweat-Chek Analyzer

21 02 90

Other Blood Gas Instruments



EDMAEDMA CODE 21 03 21 03 01


INSTRUMENTS

Instrument-Name

Electrophoresis EquipmentManual Electrophoresis Beckman Cosmo Helena Sebia Densitometers Beckman Helena Olympus SebiaPARAGON FED 3200 NN NN

21 03 02

APPRAISE NN Fractoscan Fractoscan Junior HYDRASYS

21 03 03

Automated integrated Electrophoresis Systems Beckman Eppendorf (JOOKOO) Helena

APPRAISE PARAGON CZE 2000 CTE 1000 CTE 5000 Concept 2000 REP Cardio REP PRINCE-CE AUTOIFE

Menarini Olympus

HS 7 HITE SYSTEM 310 HITE SYSTEM 320 HITE SYSTEM 620 HYDRASYS

Sebia

21 04

Chromatography Equipment





INSTRUMENTS

Instrument-Name

Urine AnalyserManual Urine Analyser MenariniMiniAution

21 05 02

Small Automated Urine Analyser Bayer Boehringer Mannheim IMACO

Clinitek 50 Clinitek 100 Urilux Minitron URIMAC

21 05 03

Medium Automated Urine Analyser Bayer Boehringer Mannheim

Clinitek 200 Clinitek 200 + Miditron Miditron Junior Urotron RL 9 RAPIMAT

Behring

21 05 04

Large Automated Urine Analyser Bayer Boehringer Mannheim IRIS Menarini Sysmex Wako Yeong Deong

Clinitek Atlas Supertron 900UDx SuperAution UF-100 NN NN

21 06 21 06 01 21 06 02 21 06 03 21 06 11 21 09

Self Testing Equipment (Clin.Chem.)Blood Glucose Meter Cholesterol Meter Lactate Meter Multi-Parameter CC Meter

Other Clinical Chemistry Instruments



EDMAEDMA CODE 22 22 01 22 01 01 22 02 22 02 01


INSTRUMENTS

Instrument-Name

IMMUNOCHEMISTRY INSTRUMENTS RIA EquipmentRIA Counter

Protein AnalyserSmall Protein Analyser Beckman Behring Bio-Whittaker Nycomed Orion Diagnostica ICS TurbiTimer Fiax Card Reader Turbox QuikRead 3

22 02 02

Large Protein Analyser Bayer Behring

Beckman

Boehringer Mannheim Sanofi Diagnostics Pasteur

DPA-1 BN 100 BNA BN II Array 2.0 Array 360 IMMAGE KeySys QM 300

22 03 22 03 01

Immunoassay AnalyserManual I.A. Instruments / Readers Abbott Matrix Quantum Quantum II Elisa-Photometer Elisa-Reader 301 Elisa-Reader 311 Berilux 250Microtrack Reader SE System

Behring

Biochem Immunosystems BioMerieux Boehringer Mannheim

Chiron Dynatech Eppendorf Hybritech Merck Murex Organon Teknika Ortho Diagnostic Systems Sanofi Diagnostics Pasteur

ECOM 6123 D Serazyme I Serazyme II Axia Microreader Axia 2 Reader ES 11 ES 22 ES 33 Magic Lite I System 5000 ECOM 6123 D Photon II Eclair LM-8 Micro ELISA Reader 7000 Micro ELISA MRX Reader Microelisa Reader 100 Microelisa System Auto Reader 3 LP 400




IVD PRODUCT CLASSIFICATIONCompany Semi-automated I.A. Systems Abbott

INSTRUMENTS

Instrument-Name

Behring

Biochem Immunosystems BioMerieux Boehringer Mannheim Byk-Sangtek Chiron

Dade DPC Dade (Dupont)

Hybritech Ortho Diag. Systems (J&J) Pharmacia Radim Roche Sorin Tosoh Wallac / Pharmacia

ADx IMx / IMx Select TDx / TDxFLx BeriLux 400 BEP II OPUS OPUS PLUS ETS Plus Solaris SR 1 VIDAS Mini-VIDAS ES 300 ElecSys 1010 LIA-mat S 300 Magic Lite II Magic Lite II+ Magic Lite SQ Allergy System Stratus I Stratus II Milenia Max Immulite ACA III ACA V ACA SX ACA STAR Photon Era Amerlite UniCAP BRIO COBAS EIA System ETI-SYSTEM AIA 600 Delfia




IVD PRODUCT CLASSIFICATIONCompany Automated I.A. Systems Abbott Bayer Behring Biochem Immunosystems Boehringer Mannheim

INSTRUMENTS

Instrument-Name AxSYM Immuno-I OPUS Magnum Labotec ES 600 ES 700 ElecSys 2010 ACS 180 ACS 180 PLUS Centaur Cispack 4200 Immulite 2000 HY-TEC 288 Quartus Ligand Immuno System Assay MAGIA 7000 MAGIA 8000 Advantage Tektime Amerlite PC Vitros ECi Ario COBAS CORE COBAS CORE II Plato 1300 Access ETI-LAB AIA 1200 AutoDELFIA Unicap 100 Commander / FPC PRISM Immage BEP III BEP XL (Micro Trak XL) Radius ELx808 MAX System 7000 Microlab F.A.M.E. HY TEC EIA System MIOS DIAS System MIAS System MPP 3000 Summit Plato 3300 AMS/LP 400 Sonata Omni System LCx ProbeTec NASBA QR System GenAmp PCR system 2400 COBAS Amplicor

Chiron

CIS-Bio DPC Hycor Kone Lisabio Merck (Biotrol) Nichols Institute Diagnostic Organon Teknika Ortho Diag. Systems (J&J) Radim Roche Rosys Sanofi Diagnostics Pasteur Sorin Tosoh Wallac / Pharmacia

22 03 04

Batch / High throughput I.A. Systems Abbott Beckman Behring Bio-Rad BIO-TEK DPC / Biermann Dynatech Hamilton Hycor Merck Murex Organon Teknika Ortho Diagnostic Systems Rosys Sanofi Diagnostics Pasteur Sorin

22 03 05

Nucleic Acid Processors Abbott Becton Dickinson Organon Teknika Perkin Elmer Roche

22 09

Other Immunochemistry Instruments



EDMAEDMA CODE 23 23 01 23 01 01 23 02 23 02 01


INSTRUMENTS

Instrument-Name

HAEMATOLOGY INSTRUMENTS Haemoglobin AnalyserDedicated Total Haemoglobin Analyser

Blood Cell CounterNo differential Blood Cell Counter Abbott CELL-DYN 300 CELL-DYN 400 CELL-DYN 500 CELL-DYN 610 CELL-DYN 700 CELL-DYN 800 CELL-DYN 900 QBC I QBC II QBC Autoread Hema-Check 5 130 150 170 7500 8000 CBC-5 M430 MD 8 ZM M530 AC 900 AC 920 Celltak MEK-5100 F-520 F-820

Becton-Dickinson

Biochmical Systems Biochem Immunosystems

Coulter

Kone Nihon Kohden Sysmex




IVD PRODUCT CLASSIFICATIONCompany 2 / 3 part differential Blood Cell Counter Abbott

INSTRUMENTS

Instrument-Name

Bayer Coulter

Diatron Hycel Kone Nihon Kohden Roche

CELL-DYN 1300 CELL-DYN 1400 CELL-DYN 1600 CELL-DYN 1700 H1JR T540 T660 MD 16 MD II S770 Twincell CELLY HEMACELL AC 970 Celltak Mini Celltak-Auto COBAS MICROS COBAS MINOS ST COBAS MINOS STE COBAS MINOS STX COBAS MINOS STEX COBAS MINOS VET 9000 9100 + 9118 + 9120 + GENIUS K-800 K-1000

Biochem Immunosystems

SEAC Sysmex

23 02 03

5 part differential low / medium end Blood Cell Counter Abbott CELL-DYN 2000 H1 Bayer Biochmical Systems Hema-Check 13 JS Coulter JR T890 S880 Onyx Hycel HEMACELL PLUS Roche COBAS HELIOS LMG COBAS HELIOS 5 Diff. Sysmex NE-1500 K-4500




IVD PRODUCT CLASSIFICATIONCompany 5 part differential high end Blood Cell Counter Abbott

INSTRUMENTS

Instrument-Name

Bayer

Coulter

Lisabio Roche

Swelab Sysmex

CELL-DYN 3000 CELL-DYN 3500 CELL-DYN 4000 H1E H2 H 3 RTC H 3 RTX STKR STKS MAXM ST Gen S Hemacell/Hemacell Plus COBAS ARGOS LMG COBAS ARGOS 5 Diff. COBAS VEGA AC920 SF-3000 SE-9000 NE-8000

23 02 11

Dedicated Reticulocyte Analyser Sysmex Sediment rate analyser COFIM Eurotec Medical System ALIFAX SR 50 VT-50/VT-75/VT-100 Test 1 R-3000

23 03 23 03 01

Flow CytometerFlow Cytometer without Cell sorter Becton-Dickinson FACScan FACStrak FACSCalibur FACSCount NN Epics Profile II Cytoron Absolute CA-II R-2000/3000

Bio-Rad Coulter Ortho Diag. Systems (J&J) Partec Sysmex

23 03 02

Flow Cytometer with Cell sorter Becton-Dickinson

FACStarPlus FACSVantage FACSort Epics Elite PAS-II

Coulter Partec





INSTRUMENTS

Instrument-Name

Coagulation SystemsManual Coagulation Instruments Amelung KC 4 KC 10 KC 10A CL4 CL8 Fibrintimer II Fibrintimer 10 Chromotimer Option 2-8 Coaguchek/Coaguchek Plus SSC-100 Cascade M-4 COA Data 1000-3000 COA System COA Screener FP 900 FP 910 Coatron F Coatron F II Thrombotrack Coag-a-Mate XM Electra 700 Koagulab CTS Fibrometer STA 2 STA 4 STA 8 STA 888 Coachrome IV

Behnk Behring

BioMerieux Boehringer Mannheim ERMA Helena Labor

Labsystems LRE Nycomed Organon Teknika Ortho Diagnostic Systems (MLA) Roche Stago

Teco Medical Instruments

23 04 02

Semi-automated Coagulation Systems Biodata Behnk Boehringer Mannheim / Stago Helena Instrumentation Laboratory

ITC-International Technidyne LRE Organon Teknika Ortho Diagnostic Systems (MLA)

MCA 110 Thrombolyzer Chrom Coasys 110 Cascade 480 ACL 100 ACL 200 ACL 300 ProTime Microcoagulation System Coatron Jr. Coatron Fx Coag-A-Mate X2 Coag-A-Mate RA 4 Electra 800 Electra 900 Electra 900 C Koagulab 16-605




IVD PRODUCT CLASSIFICATIONCompany Fully-automated Coagulation Systems Amelung Behnk Behring

INSTRUMENTS

Instrument-Name

BioMerieux Boehringer Mannheim / Stago Chiron Instrumentation Laboratory

Organon Teknika Ortho Diagnostic Systems (MLA)

KC 40 Thrombolyser Thromboyzer Combi BFA BCT BCS Hemolab STA STA Compact Biotrack 512 ACL 1000 ACL 2000 ACL 3000 ACL 3000p ACL 6000 ACL Futura Coag-A-Mate MDA Coag-A-Mate MTX Electra 1000 C Electra 1400 C Electra 1600 C Stracomat CA-1000 CA-5000 CA-6000

Stratec Sysmex / Dade

23 04 04

Aggregometer Biodata Ortho Diag. Systems / Dade PAP 4 PFA-100

23 04 05 23 05 23 05 01

Selftesting Equipment (Coagulation)

Blood Grouping InstrumentsBlood Grouping Instruments Lifescreen Menarini Olympus QUASAR 240 QUASAR 400 BOSS PK 80 PK 7100 PK 7200 AutoVue

Ortho Diag. Systems (J&J)

23 06 23 06 01

Histology Equipment (excl.microscopes)General Histology Instruments Pap Smear Screening NEOPATH

AutoPap 300 QC System

23 06 02 23 09 23 09 01

Mictrotomes

Other Haematology InstrumentsSediment rate Instruments



EDMAEDMA CODE 24 24 01 24 01 01 24 01 02


INSTRUMENTS

Instrument-Name

MICROBIOLOGY INSTRUMENTS Bacteriology InstrumentsPlate pouring Instruments Susceptibility and / or ID-systems Dade

Becton Dickinson

BioMerieux

Biokit Difco I2R Mast Radiometer

Touchscan Autoscan 4 Microscan Walkaway 40 Microscan Walkaway 96 Sceptor Autosceptor Sceptorpette Vitek Junior Vitek 32 Vitek 60 Vitek 120 Vitek 240 mini API Uniscept Aladin ATB Expression Videobact Pasco STRSCAN Radius Mastascan Sensititre

24 01 03

Blood Culture Systems Becton Dickinson

BioMerieux Difco Organon Teknika Organon Teknika Sanofi Diagnostics Pasteur

Bactec 460 Tb Bactec 660 Bactec 730 Bactec 860 Bactec 9000 MB Bactec 9050 Bactec 9120 Bactec 9240 Vital 200 Vital 1200 Sentinel ESP BacT/Alert 120 BacT/Alert 240 Bio Argos




IVD PRODUCT CLASSIFICATIONCompany Dedicated Urine Screening MB Instruments BioMerieux Coral Biotechnology Difco Lumac Orbec Sysmex

INSTRUMENTS

Instrument-Name

Bact-T-Screen 2000 URIMAT Coral Wave 120 Questor Biocounter M2300 Biocounter M3000 Ramus UF-100

24 09 26 26 01 26 02 26 02 01 26 02 02

Other Microbiology Instruments OTHER CLINICAL INSTRUMENTS Clinical Centrifuges Sample ProcessorsClinical Chemistry Sample Processors Immuno Assays Sample Processors Abbott Beckman Ortho Diag. Systems (J&J) Sanofi Diagnostics Pasteur Tecan

PPC BIOMEK 2000 Summit Plus 2 Summit Processor AMSS GENESIS RSP 200

26 02 03 26 02 04 26 02 09

Haematology Sample Processors Microbiology Sample Processors Multiple Purpose Sample Processors Boehringer Mannheim

VS 250 PPV 1200

26 03 26 03 02 26 03 03 26 03 09 26 09 27 27 01 27 02

WashersImmuno Assays Washers Haematology Washers Other Washers

Other Other Clinical Instruments DATA MANAGEMENT SYSTEMS Data Management Hardware Data Management Software/Consumables



EDMAEDMA CODE


INSTRUMENTS

Instrument-Name

Alphabetical Order by Company21 21 21 21 21 22 22 22 22 22 22 22 22 22 22 23 23 23 23 23 23 23 23 23 23 23 23 23 23 23 26 23 23 23 23 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 01 01 01 01 01 03 03 03 03 03 03 03 03 03 03 02 02 02 02 02 02 02 02 02 02 02 02 02 02 02 02 04 04 04 04 01 02 02 02 02 02 02 02 02 01 01 01 01 01 01 01 01 31 41 41 41 42 01 01 01 02 02 02 03 04 04 05 01 01 01 01 01 01 01 02 02 02 02 03 04 04 04 02 01 01 01 03 43 01 01 01 01 01 01 04 07 01 01 01 12 31 42 42 43Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Amelung Amelung Amelung Amelung American Monitor AVL AVL AVL AVL AVL AVL AVL AVL Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Vision ABA 100 / 200 VP Spectrum EPx Matrix Quantum Quantum II ADx IMx / IMx Select TDx / TDxFLx AxSYM Commander / FPC PRISM LCx CELL-DYN 300 CELL-DYN 400 CELL-DYN 500 CELL-DYN 610 CELL-DYN 700 CELL-DYN 800 CELL-DYN 900 CELL-DYN 1300 CELL-DYN 1400 CELL-DYN 1600 CELL-DYN 1700 CELL-DYN 2000 CELL-DYN 3000 CELL-DYN 3500 CELL-DYN 4000 PPC KC 4 KC 10 KC 10A KC 40 Perspective/Excel AVL 945 AVL 990 AVL 995 OPTI 1 Compact 1 Compact 2 OMNI AVL 912 ML 1 ML2 ML3 DCA 2000 Seralyzer RA2000 OPERA AXON



EDMAEDMA CODE 21 01 43 21 01 43 21 01 44 21 01 44 21 01 44 21 05 02 21 05 02 21 05 03 21 05 03 21 05 04 22 02 02 22 03 03 23 02 02 23 02 03 23 02 04 23 02 04 23 02 04 23 02 04 21 01 41 21 01 41 21 01 41 21 01 41 21 01 01 21 01 01 21 01 11 21 01 19 21 01 19 21 01 32 21 01 41 21 01 41 21 01 42 21 01 42 21 01 42 21 01 42 21 01 42 21 01 43 21 01 43 21 01 52 21 01 53 21 03 01 21 03 02 21 03 03 22 02 01 22 02 02 22 02 02 22 02 02 26 02 02 22 03 05 24 01 02 24 01 02 24 01 03 24 01 03 24 01 03 24 01 03

IVD PRODUCT CLASSIFICATIONCompany Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Becton Dickinson Becton Dickinson Becton Dickinson Becton Dickinson Becton Dickinson Becton Dickinson Becton Dickinson

INSTRUMENTS

Instrument-Name DAX 24 DAX 48 CHEM 1 DAX 72 DAX 96 Clinitek 50 Clinitek 100 Clinitek 200 Clinitek 200 + Clinitek Atlas DPA-1 Immuno-I H1JR H1 H1E H2 H 3 RTC H 3 RTX RA 50 RA 500 RA 1000 RA XT Model 42 DU 5 Glucose-Analyzer 2 Creatinine-Analyzer 2 Urea-Analyzer 2 Clinical System 700 AS 4 / AS 8 Synchron CX3 Synchron CX 3 DELTA Synchron CX 4 Synchron CX 4 DELTA Synchron CX 5 Synchron CX 5 DELTA Synchron CX 7 Synchron CX 7 DELTA E2A ELISE PARAGON APPRAISE PARAGON CZE 2000 ICS Array 2.0 Array 360 IMMAGE BIOMEK 2000 ProbeTec Sceptor Sceptorpette Bactec 460 Tb Bactec 660 Bactec 730 Bactec 860



EDMAEDMA CODE 24 01 03 24 01 03 24 01 03 24 01 03 23 02 01 23 02 01 23 02 01 23 03 01 23 03 01 23 03 01 23 03 01 23 03 02 23 03 02 23 03 02 23 04 01 23 04 01 23 04 03 21 05 03 22 02 01 22 02 02 22 02 02 22 02 02 22 03 01 22 03 01 22 03 01 22 03 01 22 03 01 22 03 01 22 03 02 22 03 02 22 03 02 22 03 02 22 03 02 22 03 02 22 03 03 22 03 04 22 03 04 23 04 01 23 04 01 23 04 01 23 04 03 23 04 03 23 04 03 21 01 12 21 01 12 22 03 04 22 03 04 22 02 01 22 03 01 22 03 01 22 03 02 22 03 03 23 02 01 23 02 01

IVD PRODUCT CLASSIFICATIONCompany Becton Dickinson Becton Dickinson Becton Dickinson Becton Dickinson Becton-Dickinson Becton-Dickinson Becton-Dickinson Becton-Dickinson Becton-Dickinson Becton-Dickinson Becton-Dickinson Becton-Dickinson Becton-Dickinson Becton-Dickinson Behnk Behnk Behnk Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Behring Bio-Rad Bio-Rad Bio-Rad BIO-TEK Bio-Whittaker Biochem Immunosystems Biochem Immunosystems Biochem Immunosystems Biochem Immunosystems Biochem Immunosystems Biochem Immunosystems

INSTRUMENTS

Instrument-Name Bactec 9000 MB Bactec 9050 Bactec 9120 Bactec 9240 QBC I QBC II QBC Autoread FACScan FACStrak FACSCalibur FACSCount Plus FACStar FACSVantage FACSort CL4 CL8 Thrombolyser RAPIMAT TurbiTimer BN 100 BNA BN II Elisa-Photometer Elisa-Reader 301 Elisa-Reader 311 Berilux 250Microtrack Reader SE System

ECOM 6123 D BeriLux 400 BEP II OPUS OPUS PLUS ETS Plus Solaris OPUS Magnum BEP III BEP XL (Micro Trak XL) Fibrintimer II Fibrintimer 10 Chromotimer BFA BCT BCS DIAMAT VARIANT Radius ELx808 Fiax Serazyme I Serazyme II SR 1 Labotec 130 150



EDMAEDMA CODE 23 02 01 23 02 01 23 02 01 23 02 02 23 02 02 23 02 02 23 02 02 23 04 02 23 04 04 24 01 02 22 03 01 22 03 01 22 03 02 22 03 02 23 04 01 23 04 03 24 01 02 24 01 02 24 01 02 24 01 02 24 01 02 24 01 02 24 01 02 24 01 02 24 01 03 24 01 03 24 01 04 24 01 04 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01 21 01 31 21 01 31 21 01 41 21 01 41 21 01 41 21 01 42 21 01 43 21 01 43 21 01 44 21 01 44 21 05 02 21 05 02 21 05 03 21 05 03 21 05 03 21 05 04 22 02 02 22 03 01 22 03 01 22 03 01 22 03 02

IVD PRODUCT CLASSIFICATIONCompany Biochem Immunosystems Biochem Immunosystems Biochem Immunosystems Biochem Immunosystems Biochem Immunosystems Biochem Immunosystems Biochem Immunosystems Biodata Biodata Biokit BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioSystems BioSystems BioSystems Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim

INSTRUMENTS

Instrument-Name 170 7500 8000 9000 9100 + 9118 + 9120 + MCA 110 PAP 4 Videobact Axia Microreader Axia 2 Reader VIDAS Mini-VIDAS Option 2-8 Hemolab Vitek Junior Vitek 32 Vitek 60 Vitek 120 Vitek 240 Uniscept Aladin ATB Expression Vital 200 Vital 1200 Bact-T-Screen 2000 URIMAT BTS 302 BTS 305 BTS 310 Photometer 4010 Photometer 4020 Reflotron Reflotron Sprint Hitachi 704 Hitachi 705 Hitachi 904 Hitachi 911 Hitachi 717 Hitachi 917 HIT 737 HIT 747 Series Urilux Minitron Miditron Miditron Junior Urotron RL 9 Supertron KeySys ES 11 ES 22 ES 33 ES 300



EDMAEDMA CODE 22 03 02 22 03 03 22 03 03 22 03 03 26 02 09 23 04 02 23 04 03 23 04 03 22 03 02 21 01 12 21 01 41 21 02 01 21 02 01 21 02 01 21 02 01 21 02 01 21 02 02 21 02 02 21 02 02 21 02 04 21 02 04 21 02 04 21 02 06 21 02 07 21 02 07 22 03 01 22 03 02 22 03 02 22 03 02 22 03 03 22 03 03 23 04 03 21 01 31 22 03 03 24 01 04 21 03 01 21 01 42 23 02 01 23 02 01 23 02 01 23 02 01 23 02 01 23 02 02 23 02 02 23 02 02 23 02 02 23 02 02 23 02 03 23 02 03 23 02 03 23 02 03 23 02 03 23 02 04 23 02 04

IVD PRODUCT CLASSIFICATIONCompany Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim / Stago Boehringer Mannheim / Stago Boehringer Mannheim / Stago Byk-Sangtek Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Cholestech CIS-Bio Coral Biotechnology COSMO Coulter Coulter Coulter Coulter Coulter Coulter Coulter Coulter Coulter Coulter Coulter Coulter Coulter Coulter Coulter Coulter Coulter Coulter

INSTRUMENTS

Instrument-Name ElecSys 1010 ES 600 ES 700 ElecSys 2010 PPV Coasys 110 STA STA Compact LIA-mat S 300 Glycomat EXPRESS CCD 238 CCD 248 CCD 278 CCD 280 CCD 840 CCD 348 CCD 850 CCD 860 CCD 845 CCD 855 CCD 865 CCD 865 CCD 270 CCD 815 Magic Lite I Magic Lite II Magic Lite II+ Magic Lite SQ Allergy System ACS 180 ACS 180 PLUS Biotrack 512 L.D.X Cispack 4200 Coral Wave 120 FED 3200 Optichem 500 CBC-5 M430 MD 8 ZM M530 T540 T660 MD 16 MD II S770 JS JR T890 S880 Onyx STKR STKS



EDMAEDMA CODE 23 02 04 23 02 04 23 03 01 23 03 02 22 03 02 22 03 02 24 01 02 24 01 02 24 01 02 24 01 02 24 01 02 21 01 41 21 01 41 21 01 43 21 01 43 21 01 43 21 01 43 22 03 02 22 03 02 22 03 02 22 03 02 21 02 02 24 01 02 24 01 03 24 01 03 24 01 04 22 03 02 22 03 02 22 03 04 22 03 01 22 03 04 21 01 01 21 01 01 21 01 01 21 01 11 21 01 29 21 01 31 21 01 32 21 01 41 21 01 41 21 01 41 21 01 41 21 01 42 21 01 42 22 03 01 21 03 03 21 03 03 21 01 01 21 01 01 22 03 04 21 03 01 21 03 02 21 03 03 21 03 03

IVD PRODUCT CLASSIFICATIONCompany Coulter Coulter Coulter Coulter Dade Dade Dade Dade Dade Dade Dade Dade (Dupont) Dade (Dupont) Dade (Dupont) Dade (Dupont) Dade (Dupont) Dade (Dupont) Dade (Dupont) Dade (Dupont) Dade (Dupont) Dade (Dupont) Diametrics Difco Difco Difco Difco DPC DPC DPC / Biermann Dynatech Dynatech Eppendorf Eppendorf Eppendorf Eppendorf Eppendorf Eppendorf Eppendorf Eppendorf Eppendorf Eppendorf Eppendorf Eppendorf Eppendorf Eppendorf Eppendorf (JOKOO) Eppendorf (JOKOO) Gilford Gilford Hamilton Helena Helena Helena Helena

INSTRUMENTS

Instrument-Name MAXM ST Epics Profile II Epics Elite Stratus I Stratus II Touchscan Autoscan 4 Microscan Walkaway 40 Microscan Walkaway 96 Autosceptor Dimension 380 Dimension ES Paramax-RX Dimension 760 Dimension AR Dimension XL ACA III ACA V ACA SX ACA STAR IRMA Pasco Sentinel ESP Questor Milenia Max Immulite MAX System 5000 System 7000 PCP 6121 ECOM 6122 ECOM 6124 F EBIO Compact EBIO Plus SPOTCHEM EPAC 6140 ACP 5040 EASY EPOS ELAN ERIS ETEC ECOM 6123 D CTE 1000 CTE 5000 103 203 Microlab F.A.M.E. NN NN Concept 2000 REP



EDMAEDMA CODE 21 03 03 21 03 03 23 04 01 23 04 02 22 03 01 22 03 02 24 01 02 21 05 02 21 01 41 21 01 42 21 01 42 21 01 43 21 01 44 21 01 51 21 01 52 21 02 01 21 02 01 21 02 01 21 02 01 21 02 01 21 02 01 21 02 01 21 02 02 21 02 02 21 02 02 21 02 02 21 02 02 21 02 02 21 02 02 21 02 02 21 02 02 21 02 02 21 02 04 21 02 07 21 02 07 23 04 02 23 04 02 23 04 02 23 04 03 23 04 03 23 04 03 23 04 03 23 04 03 23 04 03 21 01 41 21 01 41 21 01 41 21 01 41 21 01 42 21 01 42 21 01 42 21 01 42 23 02 01 23 02 01

IVD PRODUCT CLASSIFICATIONCompany Helena Helena Helena Helena Hybritech Hybritech I2R IMACO Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Kone Kone Kone Kone Kone Kone Kone Kone Kone Kone

INSTRUMENTS

Instrument-Name Cardio REP PRINCE-CE Cascade M-4 Cascade 480 Photon II Photon Era STRSCAN URIMAC Monarch 1000 Monarch PLUS Monarch 2000 ILab 900 ILab 1800 IL 943 IL 614, 644, 654 IL 1304 IL 1306 IL 1312 IL 1420 IL 1610 IL 1620 IL BG3 IL 1400 IL 1405 IL 1430 IL 1630 IL 1640 IL 1650 GEM PREMIER GEM STAT GEM 6+ GEM PREMIER PLUS Synthesis 25 /35 IL 482 IL 682 ACL 100 ACL 200 ACL 300 ACL 1000 ACL 2000 ACL 3000 ACL 3000p ACL 6000 ACL Futura Progress Progress Plus Specific Specific Supra Delta Dynamic Optima Ultra AC 900 AC 920



EDMAEDMA CODE 23 02 02 22 03 03 23 04 01 23 04 01 23 04 01 23 04 01 23 04 01 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01 23 05 01 23 05 01 23 04 01 23 04 01 23 04 02 23 04 02 24 01 04 24 01 04 24 01 02 24 01 02 21 01 12 21 01 12 21 01 12 21 01 31 21 01 41 21 01 42 21 01 42 21 03 03 21 05 01 21 05 04 23 05 01 21 01 01 21 01 01 21 01 12 21 01 31 21 01 41 21 01 43 22 03 01 22 03 01 22 03 04 22 03 03 22 03 03 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01

IVD PRODUCT CLASSIFICATIONCompany Kone Kone Labor Labor Labor Labsystems Labsystems Lange (Dr. Lange) Lange (Dr. Lange) Lange (Dr. Lange) Lange (Dr. Lange) Lange (Dr. Lange) Lange (Dr. Lange) Lifescreen Lifescreen LRE LRE LRE LRE Lumac Lumac Mast Mast Menarini Menarini Menarini Menarini Menarini Menarini Menarini Menarini Menarini Menarini Menarini Merck Merck Merck Merck Merck Merck Merck Merck Merck Merck (Biotrol) Merck (Biotrol) Milton-Roy Milton-Roy Milton-Roy Milton-Roy Milton-Roy Milton-Roy Milton-Roy Milton-Roy Milton-Roy

INSTRUMENTS

Instrument-Name AC 970 Quartus COA Data 1000-3000 COA System COA Screener FP 900 FP 910 LP 1 LP 3 LP 6A LP 400 LP 500 Miniphotometer 8 QUASAR 240 QUASAR 400 Coatron F Coatron F II Coatron Jr. Coatron Fx Biocounter M2300 Biocounter M3000 Radius Mastascan HA 8110 HA 8121 HA 8140 SPOTCHEM Classic/Artax Falcor 300 Falcor 600 HS 7 MiniAution SuperAution BOSS Eclipse Eclipse Plus Hitachi L 9000 EASY ST Selectra MEGA Eclair LM-8 MIOS MAGIA 7000 MAGIA 8000 Spectronic 1001+ Spectronic 1101 Spectronic 1201 Spectronic 20 / 20 D Spectronic 21 DV Spectronic 21 MV Spectronic 21 UVD Spectronic 3000 Spectronic 301



EDMAEDMA CODE 21 01 01 21 01 01 21 01 01 22 03 01 22 03 01 22 03 04 22 03 04 23 02 01 23 02 02 21 01 42 21 02 01 21 02 02 21 02 02 22 02 01 23 04 01 21 01 41 21 01 42 21 01 42 21 01 43 21 01 44 21 01 44 21 01 44 21 01 44 21 03 02 21 03 02 21 03 03 21 03 03 21 03 03 23 05 01 23 05 01 23 05 01 24 01 04 23 04 01 22 03 01 22 03 01 22 03 02 22 03 03 22 03 04 22 03 05 23 04 02 23 04 02 23 04 03 23 04 03 24 01 03 24 01 03 22 02 01 22 02 01 21 01 31 21 01 42 21 01 42 21 01 43 21 01 43 22 03 02 22 03 03

IVD PRODUCT CLASSIFICATIONCompany Milton-Roy Milton-Roy Milton-Roy Murex Murex Murex Murex Nihon Kohden Nihon Kohden Nova Nova Nova Biomedical Nova Biomedical Nycomed Nycomed Olympus Olympus Olympus Olympus Olympus Olympus Olympus Olympus Olympus Olympus Olympus Olympus Olympus Olympus Olympus Olympus Orbec Organon Teknika Organon Teknika Organon Teknika Organon Teknika Organon Teknika Organon Teknika Organon Teknika Organon Teknika Organon Teknika Organon Teknika Organon Teknika Organon Teknika Organon Teknika Orion Diagnostica Orion Diagnostica Ortho Diag.Syst. (J&J) Ortho Diag.Syst. (J&J) Ortho Diag.Syst. (J&J) Ortho Diag.Syst. (J&J) Ortho Diag.Syst. (J&J) Ortho Diag.Syst. (J&J) Ortho Diag.Syst. (J&J)

INSTRUMENTS

Instrument-Name Spectronic 401 Spectronic 501 Spectronic 601 Micro ELISA Reader 7000 Micro ELISA MRX Reader DIAS System MIAS System Celltak MEK-5100 Celltak-Auto Nucleus Stat Profile 3 Stat Profile1,2,4,5,7 Stat Profile Plus 9,10 Card Reader Thrombotrack AU 200 AU 510 AU 560 AU 600 AU 800 AU 1000 AU 5000 Series AU 5200 Series Fractoscan Fractoscan Junior HITE SYSTEM 310 HITE SYSTEM 320 HITE SYSTEM 620 PK 80 PK 7100 PK 7200 Ramus Coag-a-Mate XM Microelisa Reader 100 Microelisa System Auraflex Tektime MPP 3000 NASBA QR System Coag-A-Mate X2 Coag-A-Mate RA 4 Coag-A-Mate MDA Coag-A-Mate MTX BacT/Alert 120 BacT/Alert 240 Turbox QuikRead 3 VITROS(Ektachem) DT 60 VITROS(Ektachem) 250 VITROS(Ektachem) 500 VITROS(Ektachem) 750 XRC VITROS(Ektachem) 950 IRC Amerlite Amerlite PC



EDMAEDMA CODE 22 03 03 23 03 01 26 02 02 26 02 02 22 03 01 22 03 04 23 04 01 23 04 01 23 04 02 23 04 02 23 04 02 23 04 02 23 04 03 23 04 03 23 04 03 23 04 04 23 03 01 23 03 02 21 01 01 21 01 01 21 01 01 22 03 02 22 03 02 21 02 01 21 02 01 21 02 01 21 02 01 21 02 01 21 02 01 21 02 01 21 02 02 21 02 02 21 02 02 21 02 04 21 02 07 24 01 02 21 01 01 21 01 01 21 01 01 21 01 31 21 01 41 21 01 41 21 01 41 21 01 41 21 01 41 21 01 41 21 01 43 22 03 02 22 03 03 22 03 03 22 03 05 23 02 02 23 02 02 23 02 02

IVD PRODUCT CLASSIFICATIONCompany Ortho Diag.Syst. (J&J) Ortho Diag.Syst. (J&J) Ortho Diag.Syst. (J&J) Ortho Diag.Syst. (J&J) Ortho Diagnostic Systems Ortho Diagnostic Systems Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems / Dade Partec Partec Perkin-Elmer Perkin-Elmer Perkin-Elmer Pharmacia Radim Radiometer Radiometer Radiometer Radiometer Radiometer Radiometer Radiometer Radiometer Radiometer Radiometer Radiometer Radiometer Radiometer Riele Riele Riele Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche

INSTRUMENTS

Instrument-Name VITROS ECI Cytoron Absolute Summit Plus 2 Summit Processor Auto Reader 3 Summit Electra 700 Koagulab CTS Electra 800 Electra 900 Electra 900 C Koagulab 16-605 Electra 1000 C Electra 1400 C Electra 1600 C PFA-100 CA-II PAS-II Lambda 11 Lambda 12 Lambda 14 UniCAP BRIO ABL 5 ABL 30 ABL 300 ABL 330 ABL 500 ABL 510 ABL 520 ABL 4 ABL 505 ABL 620 ABL 620 OSM 3 Sensititre PMC 2000 PM 210 PM 310 COBAS Ready (=SPOTCHEM) COBAS BIO COBAS MIRA COBAS MIRA S COBAS MIRA PLUS COBAS FARA COBAS FARA II COBAS INTEGRA COBAS EIA System COBAS CORE COBAS CORE II COBAS Amplicor COBAS MICROS COBAS MINOS ST COBAS MINOS STE



EDMAEDMA CODE 23 02 02 23 02 02 23 02 02 23 02 03 23 02 03 23 02 04 23 02 04 23 02 04 23 04 01 22 03 03 22 03 04 22 02 02 22 03 01 22 03 03 22 03 04 22 03 04 24 01 03 26 02 02 23 02 02 21 03 01 21 03 02 21 03 03 22 03 03 22 03 04 23 04 01 23 04 01 23 04 01 23 04 01 23 04 03 23 02 01 23 02 01 23 02 02 23 02 02 23 02 03 23 02 03 23 02 04 23 02 04 23 02 04 23 02 11 23 03 01 24 01 04 23 04 03 23 04 03 23 04 03 26 02 02 22 03 02 22 03 03 21 01 01 21 01 01 21 01 01 21 01 01 21 01 41 21 05 04 21 01 42

IVD PRODUCT CLASSIFICATIONCompany Roche Roche Roche Roche Roche Roche Roche Roche Roche Rosys Rosys Sanofi Diagnostics Pasteur Sanofi Diagnostics Pasteur Sanofi Diagnostics Pasteur Sanofi Diagnostics Pasteur Sanofi Diagnostics Pasteur Sanofi Diagnostics Pasteur Sanofi Diagnostics Pasteur SEAC Sebia Sebia Sebia Sorin Sorin Stago Stago Stago Stago Stratec Sysmex Sysmex Sysmex Sysmex Sysmex Sysmex Sysmex Sysmex Sysmex Sysmex Sysmex Sysmex Sysmex / Dade Sysmex / Dade Sysmex / Dade Tecan Tosoh Tosoh Unicam Unicam Vitatron Vitatron Wako Wako Wako

INSTRUMENTS

Instrument-Name COBAS MINOS STX COBAS MINOS STEX COBAS MINOS VET COBAS HELIOS LMG COBAS HELIOS 5 Diff. COBAS ARGOS LMG COBAS ARGOS 5 Diff. COBAS VEGA Fibrometer Plato 1300 Plato 3300 QM 300 LP 400 Access AMS/LP 400 Sonata Bio Argos AMSS GENIUS NN NN HYDRASYS ETI System Omni System STA 2 STA 4 STA 8 STA 888 Stracomat F-520 F-820 K-800 K-1000 NE-1500 K-4500 SF-3000 SE-9000 NE-8000 R-3000 R-2000/3000 UF-100 CA-1000 CA-5000 CA-6000 GENESIS RSP 200 AIA 600 AIA 1200 PU 8610 PU 8620 IFP ISP 20R NN 30R



EDMAEDMA CODE 22 03 02 22 03 03 21 01 11 21 05 04

IVD PRODUCT CLASSIFICATIONCompany Wallac / Pharmacia Wallac / Pharmacia Yellow Springs Yeong Deong

INSTRUMENTS

Instrument-Name Delfia AutoDELFIA YSI NN



EDMAEDMA CODE


INSTRUMENTS

Instrument-Name

Alphabetical Order by Instrument Name21 23 23 23 21 23 23 23 21 21 23 23 23 21 21 21 21 21 21 21 21 21 21 21 21 23 23 23 22 22 22 22 22 23 23 23 23 23 23 23 23 23 21 22 22 22 22 22 24 22 22 22 01 02 02 02 01 02 02 02 01 01 02 02 02 01 02 02 02 02 02 02 02 02 02 02 02 02 02 02 03 03 03 03 03 04 04 04 04 04 04 04 04 04 01 03 03 03 03 03 01 03 03 03 01 01 01 01 01 01 01 02 41 42 02 02 02 41 01 01 01 02 01 01 02 01 01 02 04 01 01 02 02 02 02 02 03 02 03 02 03 02 03 03 03 03 41 03 03 02 03 02 02 02 03 04Gilford Biochem Immunosystems Biochem Immunosystems Biochem Immunosystems Gilford Biochem Immunosystems Biochem Immunosystems Biochem Immunosystems Wako Wako Biochem Immunosystems Biochem Immunosystems Biochem Immunosystems Abbott Radiometer Radiometer Radiometer Radiometer Radiometer Radiometer Radiometer Radiometer Radiometer Radiometer Radiometer Kone Kone Kone Dade (Dupont) Dade (Dupont) Dade (Dupont) Dade (Dupont) Sanofi Diagnostics Pasteur Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Eppendorf Chiron (Ciba Corning) Chiron (Ciba Corning) Abbott Tosoh Tosoh BioMerieux Ortho Diag.Syst. (J&J) Ortho Diag.Syst. (J&J) Sanofi Diagnostics Pasteur 103 130 150 170 203 7500 8000 9000 20R 30R 9100 + 9118 + 9120 + ABA 100 / 200 ABL 30 ABL 300 ABL 330 ABL 4 ABL 5 ABL 500 ABL 505 ABL 510 ABL 520 ABL 620 ABL 620 AC 900 AC 920 AC 970 ACA III ACA STAR ACA SX ACA V Access ACL 100 ACL 1000 ACL 200 ACL 2000 ACL 300 ACL 3000 ACL 3000p ACL 6000 ACL Futura ACP 5040 ACS 180 ACS 180 PLUS ADx AIA 1200 AIA 600 Aladin Amerlite Amerlite PC AMS/LP 400



EDMAEDMA CODE 26 02 02 21 03 02 22 02 02 22 02 02 21 01 41 24 01 02 21 01 44 21 01 41 21 01 44 21 01 42 21 01 44 21 01 42 21 01 43 21 01 44 22 03 02 22 03 01 22 03 03 24 01 02 24 01 02 21 02 07 21 02 01 21 02 01 21 02 01 22 03 01 22 03 01 21 01 43 22 03 03 24 01 04 24 01 03 24 01 03 24 01 03 24 01 03 24 01 03 24 01 03 24 01 03 24 01 03 24 01 03 24 01 03 23 04 03 23 04 03 22 03 02 22 03 04 22 03 04 22 03 01 22 03 02 23 04 03 24 01 03 24 01 04 24 01 04 26 02 02 23 04 03 22 02 02 22 02 02 22 02 02

IVD PRODUCT CLASSIFICATIONCompany Sanofi Diagnostics Pasteur Beckman Beckman Beckman Beckman BioMerieux Olympus Olympus Olympus Olympus Olympus Olympus Olympus Olympus Organon Teknika Ortho Diagnostic Systems Wallac / Pharmacia Dade Dade AVL AVL AVL AVL BioMerieux BioMerieux Bayer Abbott BioMerieux Organon Teknika Organon Teknika Becton Dickinson Becton Dickinson Becton Dickinson Becton Dickinson Becton Dickinson Becton Dickinson Becton Dickinson Becton Dickinson Behring Behring Behring Behring Behring Behring Behring Behring Sanofi Diagnostics Pasteur Lumac Lumac Beckman Chiron (Ciba Corning) Behring Behring Behring

INSTRUMENTS

Instrument-Name AMSS APPRAISE Array 2.0 Array 360 AS 4 / AS 8 ATB Expression AU 1000 AU 200 AU 5000 Series AU 510 AU 5200 Series AU 560 AU 600 AU 800 Auraflex Auto Reader 3 AutoDELFIA Autoscan 4 Autosceptor AVL 912 AVL 945 AVL 990 AVL 995 Axia 2 Reader Axia Microreader AXON AxSYM Bact-T-Screen 2000 BacT/Alert 120 BacT/Alert 240 Bactec 460 Tb Bactec 660 Bactec 730 Bactec 860 Bactec 9000 MB Bactec 9050 Bactec 9120 Bactec 9240 BCS BCT BEP II BEP III BEP XL (Micro Trak XL) Berilux 250 BeriLux 400 BFA Bio Argos Biocounter M2300 Biocounter M3000 BIOMEK 2000 Biotrack 512 BN 100 BN II BNA



EDMAEDMA CODE 23 05 01 22 03 02 21 01 01 21 01 01 21 01 01 23 04 03 23 04 03 23 04 03 23 03 01 22 02 01 21 03 03 23 04 02 23 04 01 23 02 01 21 02 01 21 02 01 21 02 07 21 02 01 21 02 01 21 02 02 21 02 07 21 02 01 21 02 04 21 02 02 21 02 04 21 02 02 21 02 04 21 02 06 23 02 02 23 02 02 23 02 02 23 02 02 23 02 03 23 02 01 23 02 04 23 02 04 23 02 01 23 02 04 23 02 01 23 02 01 23 02 01 23 02 01 23 02 01 23 02 01 23 02 02 21 01 44 23 04 01 22 03 03 23 04 01 23 04 01 21 01 41 21 01 32 21 05 02 21 05 03

IVD PRODUCT CLASSIFICATIONCompany Menarini Radim BioSystems BioSystems BioSystems Sysmex / Dade Sysmex / Dade Sysmex / Dade Partec Nycomed Helena Helena Helena Coulter Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Abbott Nihon Kohden Nihon Kohden Bayer Behring CIS-Bio Behnk Behnk Menarini Beckman Bayer Bayer

INSTRUMENTS

Instrument-Name BOSS BRIO BTS 302 BTS 305 BTS 310 CA-1000 CA-5000 CA-6000 CA-II Card Reader Cardio REP Cascade 480 Cascade M-4 CBC-5 CCD 238 CCD 248 CCD 270 CCD 278 CCD 280 CCD 348 CCD 815 CCD 840 CCD 845 CCD 850 CCD 855 CCD 860 CCD 865 CCD 865 CELL-DYN 1300 CELL-DYN 1400 CELL-DYN 1600 CELL-DYN 1700 CELL-DYN 2000 CELL-DYN 300 CELL-DYN 3000 CELL-DYN 3500 CELL-DYN 400 CELL-DYN 4000 CELL-DYN 500 CELL-DYN 610 CELL-DYN 700 CELL-DYN 800 CELL-DYN 900 Celltak MEK-5100 Celltak-Auto CHEM 1 Chromotimer Cispack 4200 CL4 CL8 Classic/Artax Clinical System 700 Clinitek 100 Clinitek 200



EDMAEDMA CODE 21 05 03 21 05 02 21 05 04 23 04 01 23 04 01 23 04 01 23 04 03 23 04 03 23 04 02 23 04 02 23 04 01 23 04 02 23 04 01 23 04 01 23 04 02 23 04 02 22 03 05 23 02 04 23 02 04 21 01 41 22 03 03 22 03 03 22 03 02 21 01 41 21 01 41 23 02 03 23 02 03 21 01 43 23 02 02 23 02 02 23 02 02 23 02 02 23 02 02 23 02 02 21 01 41 21 01 41 21 01 41 21 01 31 23 02 04 22 03 04 21 02 01 21 02 01 21 03 03 24 01 04 21 01 19 21 03 03 21 03 03 23 03 01 21 01 43 21 01 43 21 01 44 21 01 44 21 01 12 22 03 02

IVD PRODUCT CLASSIFICATIONCompany Bayer Bayer Bayer Labor Labor Labor Organon Teknika Organon Teknika Organon Teknika Organon Teknika Organon Teknika Boehringer Mannheim / Stago LRE LRE LRE LRE Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Roche Abbott AVL AVL Helena Coral Biotechnology Beckman Eppendorf (JOKOO) Eppendorf (JOKOO) Ortho Diag.Syst. (J&J) Bayer Bayer Bayer Bayer Bayer Wallac / Pharmacia

INSTRUMENTS

Instrument-Name Clinitek 200 + Clinitek 50 Clinitek Atlas COA Data 1000-3000 COA Screener COA System Coag-A-Mate MDA Coag-A-Mate MTX Coag-A-Mate RA 4 Coag-A-Mate X2 Coag-a-Mate XM Coasys 110 Coatron F Coatron F II Coatron Fx Coatron Jr. COBAS Amplicor COBAS ARGOS 5 Diff. COBAS ARGOS LMG COBAS BIO COBAS CORE COBAS CORE II COBAS EIA System COBAS FARA COBAS FARA II COBAS HELIOS 5 Diff. COBAS HELIOS LMG COBAS INTEGRA COBAS MICROS COBAS MINOS ST COBAS MINOS STE COBAS MINOS STEX COBAS MINOS STX COBAS MINOS VET COBAS MIRA COBAS MIRA PLUS COBAS MIRA S COBAS Ready (=SPOTCHEM) COBAS VEGA Commander / FPC Compact 1 Compact 2 Concept 2000 Coral Wave 120 Creatinine-Analyzer 2 CTE 1000 CTE 5000 Cytoron Absolute DAX 24 DAX 48 DAX 72 DAX 96 DCA 2000 Delfia



EDMAEDMA CODE 21 01 42 21 01 12 22 03 04 21 01 41 21 01 43 21 01 43 21 01 41 21 01 43 22 02 02 21 01 01 21 01 42 21 01 52 21 01 41 21 01 31 21 01 11 21 01 29 22 03 01 21 01 01 21 01 01 21 01 01 22 03 01 22 03 01 21 01 01 21 01 41 22 03 02 22 03 03 23 04 03 23 04 03 23 04 03 23 04 01 23 04 02 23 04 02 23 04 02 22 03 01 22 03 01 22 03 01 21 01 53 22 03 04 21 01 32 23 03 02 23 03 01 21 01 41 21 01 42 21 01 42 22 03 01 22 03 01 22 03 02 22 03 01 22 03 03 22 03 03 24 01 03 21 01 42 22 03 03 22 03 02

IVD PRODUCT CLASSIFICATIONCompany Kone Bio-Rad Murex Dade (Dupont) Dade (Dupont) Dade (Dupont) Dade (Dupont) Dade (Dupont) Bayer Beckman Kone Beckman Eppendorf Merck Eppendorf Eppendorf Merck Merck Merck Eppendorf Behring Eppendorf Eppendorf Eppendorf Boehringer Mannheim Boehringer Mannheim Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems (MLA) Behring Behring Behring Beckman BIO-TEK Eppendorf Coulter Coulter Eppendorf Abbott Eppendorf Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Difco Eppendorf Sorin Behring

INSTRUMENTS

Instrument-Name Delta DIAMAT DIAS System Dimension 380 Dimension 760 Dimension AR Dimension ES Dimension XL DPA-1 DU 5 Dynamic E2A EASY EASY ST EBIO Compact EBIO Plus Eclair Eclipse Eclipse Plus ECOM 6122 ECOM 6123 D ECOM 6123 D ECOM 6124 F ELAN ElecSys 1010 ElecSys 2010 Electra 1000 C Electra 1400 C Electra 1600 C Electra 700 Electra 800 Electra 900 Electra 900 C Elisa-Photometer Elisa-Reader 301 Elisa-Reader 311 ELISE ELx808 EPAC 6140 Epics Elite Epics Profile II EPOS EPx ERIS ES 11 ES 22 ES 300 ES 33 ES 600 ES 700 ESP ETEC ETI System ETS Plus



EDMAEDMA CODE 21 01 41 23 02 01 23 02 01 23 03 01 23 03 01 23 03 01 23 03 02 23 03 02 23 03 01 23 03 02 21 01 42 21 01 42 21 03 01 22 02 01 23 04 01 23 04 01 23 04 01 23 04 01 23 04 01 21 03 02 21 03 02 21 02 02 21 02 02 21 02 02 21 02 02 26 02 02 23 02 02 21 01 11 21 01 12 23 02 04 23 02 04 23 02 04 23 02 04 23 02 03 23 02 02 21 01 12 21 01 12 21 01 12 23 04 03 21 01 44 21 01 44 21 01 12 21 01 41 21 01 41 21 01 43 21 01 41 21 01 42 21 01 43 21 03 03 21 03 03 21 03 03 21 03 03 21 03 03 22 02 01

IVD PRODUCT CLASSIFICATIONCompany Chiron (Ciba Corning) Sysmex Sysmex Becton-Dickinson Becton-Dickinson Becton-Dickinson Becton-Dickinson Becton-Dickinson Becton-Dickinson Becton-Dickinson Menarini Menarini COSMO Bio-Whittaker Behring Behring Roche Labsystems Labsystems Olympus Olympus Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Tecan SEAC Beckman Chiron (Ciba Corning) Bayer Bayer Bayer Bayer Bayer Bayer Menarini Menarini Menarini BioMerieux Boehringer Mannheim Boehringer Mannheim Merck Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Boehringer Mannheim Olympus Olympus Olympus Menarini Sebia Beckman

INSTRUMENTS

Instrument-Name EXPRESS F-520 F-820 FACSCalibur FACScan FACSCount FACSort Plus FACStar FACStrak FACSVantage Falcor 300 Falcor 600 FED 3200 Fiax Fibrintimer 10 Fibrintimer II Fibrometer FP 900 FP 910 Fractoscan Fractoscan Junior GEM 6+ GEM PREMIER GEM PREMIER PLUS GEM STAT GENESIS RSP 200 GENIUS Glucose-Analyzer 2 Glycomat H1E H2 H 3 RTC H 3 RTX H1 H1JR HA 8110 HA 8121 HA 8140 Hemolab HIT 737 HIT 747 Series Hitachi L 9000 Hitachi 704 Hitachi 705 Hitachi 717 Hitachi 904 Hitachi 911 Hitachi 917 HITE SYSTEM 310 HITE SYSTEM 320 HITE SYSTEM 620 HS 7 HYDRASYS ICS



EDMAEDMA CODE 21 01 01 21 02 01 21 02 01 21 02 01 21 02 02 21 02 02 21 02 01 21 02 02 21 02 01 21 02 01 21 02 02 21 02 02 21 02 02 21 02 07 21 01 52 21 02 07 21 01 51 21 02 01 21 01 44 21 01 43 22 02 02 22 03 02 22 03 03 22 03 02 21 02 02 21 01 01 23 02 03 23 02 03 23 02 02 23 02 03 23 02 02 23 04 01 23 04 01 23 04 01 23 04 03 22 02 02 23 04 02 23 04 01 21 01 31 22 03 03 21 01 01 21 01 01 21 01 01 22 03 05 22 03 02 22 03 01 21 01 01 21 01 01 21 01 01 22 03 01 21 01 01 21 01 01 23 02 01 23 02 01

IVD PRODUCT CLASSIFICATIONCompany Vitatron Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Beckman DPC Bayer Abbott Diametrics Vitatron Coulter Coulter Sysmex Sysmex Sysmex Amelung Amelung Amelung Amelung Boehringer Mannheim Ortho Diagnostic Systems (MLA) Ortho Diagnostic Systems (MLA) Cholestech Biochem Immunosystems Perkin-Elmer Perkin-Elmer Perkin-Elmer Abbott Byk-Sangtek Merck Lange (Dr. Lange) Lange (Dr. Lange) Lange (Dr. Lange) Sanofi Diagnostics Pasteur Lange (Dr. Lange) Lange (Dr. Lange) Coulter Coulter

INSTRUMENTS

Instrument-Name IFP IL 1304 IL 1306 IL 1312 IL 1400 IL 1405 IL 1420 IL 1430 IL 1610 IL 1620 IL 1630 IL 1640 IL 1650 IL 482 IL 614, 644, 654 IL 682 IL 943 IL BG3 ILab 1800 ILab 900 IMMAGE Immulite Immuno-I IMx / IMx Select IRMA ISP JR JS K-1000 K-4500 K-800 KC 10 KC 10A KC 4 KC 40 KeySys Koagulab 16-605 Koagulab CTS L.D.X Labotec Lambda 11 Lambda 12 Lambda 14 LCx LIA-mat S 300 LM-8 LP 1 LP 3 LP 400 LP 400 LP 500 LP 6A M430 M530



EDMAEDMA CODE 22 03 03 22 03 03 22 03 01 22 03 02 22 03 02 22 03 02 24 01 02 22 03 01 22 03 04 23 02 04 23 04 02 23 02 02 23 02 01 23 02 02 21 01 43 22 03 04 22 03 01 22 03 01 22 03 01 22 03 01 22 03 04 24 01 02 24 01 02 22 03 01 21 05 03 21 05 03 22 03 02 22 03 02 21 05 01 21 01 01 21 05 02 22 03 04 21 01 01 21 01 01 21 01 01 21 01 01 21 01 41 21 01 42 21 01 42 22 03 04 22 03 05 23 02 03 23 02 04 21 03 01 21 03 02 21 03 01 21 03 02 21 05 04 21 05 04 21 01 42 21 02 04 22 03 04 23 02 03 21 01 42

IVD PRODUCT CLASSIFICATIONCompany Merck (Biotrol) Merck (Biotrol) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Chiron (Ciba Corning) Mast Abbott DPC / Biermann Coulter Biodata Coulter Coulter Coulter Merck Murex Murex Murex Organon Teknika Organon Teknika Hamilton Dade Dade Behring Boehringer Mannheim Boehringer Mannheim DPC BioMerieux Menarini Lange (Dr. Lange) Boehringer Mannheim Merck Bayer Bayer Bayer Beckman Instrument. Lab. (IL) Instrument. Lab. (IL) Instrument. Lab. (IL) Organon Teknika Organon Teknika Sysmex Sysmex Helena Helena Sebia Sebia Wako Yeong Deong Nova AVL Sorin Coulter Bayer

INSTRUMENTS

Instrument-Name MAGIA 7000 MAGIA 8000 Magic Lite I Magic Lite II Magic Lite II+ Magic Lite SQ Allergy System Mastascan Matrix MAX MAXM MCA 110 MD 16 MD 8 MD II MEGA MIAS System Micro ELISA MRX Reader Micro ELISA Reader 7000 Microelisa Reader 100 Microelisa System Microlab F.A.M.E. Microscan Walkaway 40 Microscan Walkaway 96Microtrack Reader SE System

Miditron Miditron Junior Milenia Max Mini-VIDAS MiniAution Miniphotometer 8 Minitron MIOS ML 1 ML2 ML3 Model 42 Monarch 1000 Monarch 2000 Monarch PLUS MPP 3000 NASBA QR System NE-1500 NE-8000 NN NN NN NN NN NN Nucleus OMNI Omni System Onyx OPERA



EDMAEDMA CODE 21 02 01 21 01 42 21 01 42 23 04 01 22 03 02 22 03 03 22 03 02 21 02 07 23 04 04 21 03 01 21 03 03 21 01 43 23 03 02 24 01 02 21 01 01 21 01 43 23 04 04 21 01 01 21 01 01 22 03 02 22 03 01 23 05 01 23 05 01 23 05 01 22 03 03 22 03 04 21 01 01 21 01 01 21 01 01 26 02 02 26 02 09 21 03 03 22 03 04 22 03 05 21 01 41 21 01 41 21 01 01 21 01 01 23 02 01 23 02 01 23 02 01 22 02 02 22 03 01 22 03 01 22 03 03 23 05 01 23 05 01 24 01 04 22 02 01 23 03 01 23 02 11 21 01 41 21 01 41 21 01 41

IVD PRODUCT CLASSIFICATIONCompany AVL Coulter Kone BioMerieux Behring Behring Behring Radiometer Biodata Beckman Beckman Dade (Dupont) Partec Difco Eppendorf American Monitor Ortho Diagnostic Systems / Dade Boehringer Mannheim Boehringer Mannheim Hybritech Hybritech Olympus Olympus Olympus Rosys Rosys Riele Riele Riele Abbott Boehringer Mannheim Helena Abbott Becton Dickinson Kone Kone Unicam Unicam Becton-Dickinson Becton-Dickinson Becton-Dickinson Sanofi Diagnostics Pasteur Abbott Abbott Kone Lifescreen Lifescreen Difco Orion Diagnostica Sysmex Sysmex Bayer Bayer Bayer

INSTRUMENTS

Instrument-Name OPTI 1 Optichem 500 Optima Option 2-8 OPUS OPUS Magnum OPUS PLUS OSM 3 PAP 4 PARAGON PARAGON CZE 2000 Paramax-RX PAS-II Pasco PCP 6121 Perspective/Excel PFA-100 Photometer 4010 Photometer 4020 Photon Era Photon II PK 7100 PK 7200 PK 80 Plato 1300 Plato 3300 PM 210 PM 310 PMC 2000 PPC PPV PRINCE-CE PRISM ProbeTec Progress Progress Plus PU 8610 PU 8620 QBC Autoread QBC I QBC II QM 300 Quantum Quantum II Quartus QUASAR 240 QUASAR 400 Questor QuikRead 3 R-2000/3000 R-3000 RA 1000 RA 50 RA 500



EDMAEDMA CODE 21 01 41 21 01 42 22 03 04 24 01 02 24 01 04 21 05 03 21 01 31 21 01 31 21 03 03 23 02 02 23 02 03 24 01 02 24 01 02 23 02 04 21 01 41 24 01 02 24 01 03 21 01 31 22 03 01 22 03 01 23 02 04 22 03 02 22 03 04 21 01 41 21 01 41 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01 21 01 01 21 01 41 21 01 31 21 01 31 22 03 02 23 02 04 23 04 03 23 04 01 23 04 01 23 04 01 23 04 01 23 04 03 21 02 01 21 02 02 21 02 02 23 02 04 23 02 04 23 04 03

IVD PRODUCT CLASSIFICATIONCompany Bayer Bayer Bio-Rad Mast Orbec Behring Boehringer Mannheim Boehringer Mannheim Helena Coulter Coulter Becton Dickinson Becton Dickinson Sysmex Merck Radiometer Difco Bayer Biochem Immunosystems Biochem Immunosystems Sysmex Behring Sanofi Diagnostics Pasteur Kone Kone Milton-Roy Milton-Roy Milton-Roy Milton-Roy Milton-Roy Milton-Roy Milton-Roy Milton-Roy Milton-Roy Milton-Roy Milton-Roy Milton-Roy Abbott Eppendorf Menarini Biochem Immunosystems Coulter Boehringer Mannheim / Stago Stago Stago Stago Stago Boehringer Mannheim / Stago Nova Nova Biomedical Nova Biomedical Coulter Coulter Stratec

INSTRUMENTS

Instrument-Name RA XT RA2000 Radius Radius Ramus RAPIMAT Reflotron Reflotron Sprint REP S770 S880 Sceptor Sceptorpette SE-9000 Selectra Sensititre Sentinel Seralyzer Serazyme I Serazyme II SF-3000 Solaris Sonata Specific Specific Supra Spectronic 1001+ Spectronic 1101 Spectronic 1201 Spectronic 20 / 20 D Spectronic 21 DV Spectronic 21 MV Spectronic 21 UVD Spectronic 3000 Spectronic 301 Spectronic 401 Spectronic 501 Spectronic 601 Spectrum SPOTCHEM SPOTCHEM SR 1 ST STA STA 2 STA 4 STA 8 STA 888 STA Compact Stat Profile 3 Stat Profile Plus 9,10 Stat Profile1,2,4,5,7 STKR STKS Stracomat



EDMAEDMA CODE 22 03 02 22 03 02 24 01 02 22 03 04 26 02 02 26 02 02 21 05 04 21 05 04 21 01 42 21 01 42 21 01 42 21 01 42 21 01 42 21 01 43 21 01 43 21 01 41 21 02 04 22 03 01 22 03 04 23 02 02 23 02 02 23 02 03 22 03 02 22 03 03 23 04 03 23 04 01 24 01 02 22 02 01 22 02 01 24 01 04 21 01 42 22 03 02 24 01 02 21 01 19 21 05 02 21 05 02 24 01 04 21 05 03 21 01 12 22 03 02 24 01 02 21 01 31 24 01 03 24 01 03 24 01 02 24 01 02 24 01 02 24 01 02 24 01 02 22 03 03 21 01 42 21 01 42 21 01 43 21 01 43

IVD PRODUCT CLASSIFICATIONCompany Dade Dade I2R Ortho Diagnostic Systems Ortho Diag.Syst. (J&J) Ortho Diag.Syst. (J&J) Menarini Boehringer Mannheim Beckman Beckman Beckman Beckman Beckman Beckman Beckman Beckman Instrument. Lab. (IL) Dynatech Dynatech Coulter Coulter Coulter Abbott Organon Teknika Behnk Nycomed Dade Behring Orion Diagnostica Sysmex Kone Pharmacia BioMerieux Beckman Boehringer Mannheim IMACO BioMerieux Boehringer Mannheim Bio-Rad BioMerieux Biokit Abbott BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux BioMerieux Ortho Diag.Syst. (J&J) Ortho Diag.Syst. (J&J) Ortho Diag.Syst. (J&J) Ortho Diag.Syst. (J&J) Ortho Diag.Syst. (J&J)

INSTRUMENTS

Instrument-Name Stratus I Stratus II STRSCAN Summit Summit Plus 2 Summit Processor SuperAution Supertron Synchron CX 3 DELTA Synchron CX 4 Synchron CX 4 DELTA Synchron CX 5 Synchron CX 5 DELTA Synchron CX 7 Synchron CX 7 DELTA Synchron CX3 Synthesis 25 /35 System 5000 System 7000 T540 T660 T890 TDx / TDxFLx Tektime Thrombolyser Thrombotrack Touchscan TurbiTimer Turbox UF-100 Ultra UniCAP Uniscept Urea-Analyzer 2 Urilux URIMAC URIMAT Urotron RL 9 VARIANT VIDAS Videobact Vision Vital 1200 Vital 200 Vitek 120 Vitek 240 Vitek 32 Vitek 60 Vitek Junior VITROS ECI VITROS(Ektachem) 250 VITROS(Ektachem) 500 VITROS(Ektachem) 750 XRC VITROS(Ektachem) 950 IRC



EDMAEDMA CODE 21 01 31 21 01 41 21 01 11 23 02 01

IVD PRODUCT CLASSIFICATIONCompany Ortho Diag.Syst. (J&J) Abbott Yellow Springs Coulter

INSTRUMENTS

Instrument-Name VITROS(Ektachem) DT 60 VP YSI ZM



Documents

Edma Classification Instrument