POCT catalogue

Product CatalogueProduct CatalogueIVD Industry

POCT Leading Brand

TUVRheinlandR

R

Getein Biotech, Inc. founded in March 2002, headquartered in

Nanjing, is a modern high-tech biotechnology company

specialized in developing, manufacturing and marketing in-

vitro diagnostic reagents and medical devices.

Getein achieved the Rheinland TÜV ISO 13485:2012 quality

management system cert i f icat ion and CE cert i f icat ion

sequentially, which ensure the quality, reliability and stability.

Until now, Getein has three product lines to assist disease

detection, monitoring and management, they are point-of-

care, clinical chemistry and raw material. Our R&D team is

devoted to providing you with more accurate and reliable

products, expanding our products portfolio.

ompany profile

2002Founded

762Employees

2000 GMP Workshop

246Researchers

Getein was Founded Founded in Nanjing, 17000 square meters of Getein’s total construction

area and 2,000 square meters GMP workshop.

Team ConstructionFocused on the rapid diagnosis scientific research.

Established a professional R&D team.

Domestic SalesCardiac test kits became available.

Occupied the domestic market.

ISO Certification and CE MarkAchieved the Rheinland TÜV ISO 13485:2012 quality management

system certification and CE certification.

Overseas SalesStarted the POCT business in Asia, the Middle East, Africa, lndia and etc.

Expand product lines: POCT, clinical chemistry and raw material.

Expand the market15000 domestic hospital users.

More than 1000 distributors and 50 strategic partners.

Pursue Excellence/Deliver Health Getein aims to become the world leading enterprise and is committed to

delivering health for global population.

C

GeteinHistory

2002

2003-2007

2008-2010

2011

2012-2013

2014-2015

Future

hs-CRP

PCT

D-Dimer

cTnI

NT-proBNP

CK-MB/cTnI/Myo

NT-proBNP/cTnI

PCT/CRP

CK-MB

CK-MB/cTnI

H-FABP

CK-MB/cTnI/H-FABP

NGAL

mAlb

CysC

HbA1c (Diabetes)

HCG (Fertility)

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Product List

Application Departments

01

Getein IntroductionProduct List

Getein1600 Immunofluorescence Quantitative Analyzer

FIA8000 Quantitative Analyzer

Getein1100 Immunofluorescence Quantitative Analyzer

Partners/Exhibitions Certificates

01

02

04

06

08

10

CatalogueCatalogue

Gynecology Dept.

Gastroenterology Dept.

Respiratory Dept.

Urology Dept.

Getein’s products can be widely applied to many clinical departments as follows:Cardiology Dept.

Emergency Dept.

Oncology Dept.

Pediatrics Dept.

Clinical Laboratory

ICU

Nephrology Dept.

Endocrinology Dept.

Qualitative Products

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FIA8000Getein1600 Getein1100 Qualitative Products

09 Controls

Getein1600 Parameters

Performance CharacteristicsFully automated

10.4 inch LCD touch screen

Automatic item test&result print

Routine and emergency mode

cTnI

NT-proBNP

Myocardial infarction

Cardiovascular inflammatory

diseases;Inflammatory

disorders

Venous thromboembolism;

Pulmonary embolism

0.1~50.0ng/ml

100~35000pg/ml

PCT

Disease Measuring Range

Heart failure

D-Dimer 0.1~10.0mg/L

0.5~200.0mg/Lhs-CRP

Reaction Time15min

10min

15min

SampleCat.#

IF 1001

IF 1002

IF 1003

IF 1005

IF 1006

IF 1007

Cut-offValue

S/P/W.B/

Fingertip Blood

0.1ng/ml

300pg/ml

3mg/L

10mg/L

S/P/W.B

S/P/W.B

3min

2.5~80.0ng/ml0.1~50.0ng/ml30~600ng/ml

CK-MB/cTnI/Myo

Myocardial injury 15minS/P/W.B

5ng/ml0.1ng/ml70ng/ml

10min0.5mg/L

0.1ng/mlS/P/W.B

P/W.B

0.1~50ng/mlSepsis; Septic shock

Getein1600Immunouorescence Quantitative Analyzer

H-FABP

D-Dimer

hs-CRP PCT

HCG

β2 - MG mAlb CysC

Test Items

Up to 48 samples per run

Maximum 150 tests per hour

Minimum 10 l sample volume

PC/LIS/HIS connectivity

0302

CARDIAC

VENOUS THROMBOEMBOLISM

INFLAMMATION MONITORING

FERTILITY

RENAL FUNCTION NGAL

NT-proBNP/cTnI NT-proBNP cTnI CK-MB/cTnI/Myo

CK-MB/cTnI/H-FABP

Test Item

IF 1004NT-proBNP

/cTnI

100-15000pg/ml

0.1-50ng/mlS/P/W.B

300pg/mL

0.1ng/ml 15minHeart failure;

Acute coronary syndrome

CysC

Early diagnosis of kidney disease;

Detection of kidney damage for

surgery patients0.5~10.0mg/L S/P/W.B 0.51~1.09

mg/L3minIF 1008

IF 1010 NGAL The best indicator of early renal injury 50~1500ng/ml Urine 135ng/ml 3min

IF 1011 β 2-MGKidney damage for

diabetic& hypertensive

patients0.5~20.0mg/L S/P/W.B 0.8~3.0

mg/L 3min

IF 1013

IF 1017

HCG

HbA1c

Pregnancy early test

Diabetes mellitus

25~10000mIU/ml

2%~14%

S/P

W.B

25mIU/ml

3.8%~5.8%

10min

5min

Micro Printer

cTnI

NT-proBNP




disorders


Pulmonary embolism

0.5~50.0ng/ml

100~35000pg/ml

PCT

Heart failure


0.5~200.0mg/Lhs-CRP

15min

15min

15min

CG 1002

CG 1003

CG 1005

CG 1006

CG 1007

S/P/W.B/fingertip blood

0.5ng/ml

300pg/ml

3mg/L10mg/L

S/P/W.B

S/P/W.B

90s

2.5~80.0ng/ml0.5~50.0ng/ml30~600ng/ml

CK-MB/cTnI/Myo


5ng/ml0.5ng/ml70ng/ml

7min0.5mg/L

0.1ng/mLS/P/W.B

P/W.B


CG 1009

CG 1010

CG 1011

CG 1013

CG 1017

CysC

mAlb

NGAL

β 2-MG

HCG

HbA1c



surgery patients

Early diagnosis and evaluation

of diabetic nephropathy

The best indicator of early renal injury

Kidney damage for diabetic

& hypertensive patients


Diabetes mellitus

0.5~10.0mg/L

10~200mg/L

50~1500ng/ml

0.5~20.0mg/L

25~10000mIU/ml

2%~14%

S/P/W.B

Urine

Urine

S/P/W.B

S

W.B

0.51~1.09mg/L

20mg/ml

135ng/ml

0.8~3.0mg/L

25mIU/ml

3.8%~5.8%

3min

3min

3min

3min

10min

10min

CG 1008

CG 1004 NT-proBNP

/cTnI

Heart failure; Acute coronary

syndrome

100~12000pg/ml

0.5~50ng/mlS/P/W.B

300pg/mL

0.5ng/ml18min

CG 1001

FIA8000Quantitative Immunoassay Analyzer

User friendly

Small and light

Touch screen

Automatic barcode identification&result print

Performance Characteristics

FIA8000 Parameters

Touch Screen

Keypad

SD Card Slot

Power Switch&Connection Port

Test Card Slot

Comprehensive POCT markers available

Result available in 3~5s

Accurate in detection results

PC/LIS/HIS connectivity

0504


Reaction TimeSampleCat.# Cut-off

ValueTest Item

Test Cards

CG 1018 CK-MB 2.5~80.0ng/mlMyocardial injury 15minS/P/W.B 5ng/ml

CG 1012CK-MB/cTnI

Myocardial injury 15minS/P/W.B5ng/ml

0.5ng/ml

2.5~80.0ng/ml0.5~50.0ng/ml

cTnI

NT-proBNP




disorders


Pulmonary embolism

0.1~50.0ng/ml

100~35000pg/ml

PCT

Heart failure


0.5~200.0mg/Lhs-CRP

15min

10min

15min

IF 1001

IF 1002

IF 1003

IF 1005

IF 1006

IF 1007

S/P/W.B/fingertip blood

0.1ng/ml

300pg/ml

3mg/L10mg/L

S/P/W.B

S/P/W.B

3min

2.5~80.0ng/ml0.1~50.0ng/ml30~600ng/ml

CK-MB/cTnI/Myo


5ng/ml0.1ng/ml

70ng/ml

10min0.5mg/L

0.1ng/mLS/P/W.B

P/W.B


IF 1009

IF 1010

IF 1011

IF 1013

IF 1017

CysC

mAlb

NGAL

β 2-MG

HCG

HbA1c



surgery patients

Early diagnosis and evaluation

of diabetic nephropathy

The best indicator of early renal injury

Kidney damage for diabetic

& hypertensive patients


Diabetes mellitus

0.5~10.0mg/L

10~200mg/L

50~1500ng/ml

0.5~20.0mg/L

25~10000mIU/ml

2%~14%

S/P/W.B

Urine

Urine

S/P/W.B

S/P

W.B

0.51~1.09mg/L

20mg/ml

135ng/ml

0.8~3.0mg/L

25mIU/ml

3.8%~5.8%

3min

3min

3min

3min

10min

5min

IF 1008

IF 1004 NT-proBNP

/cTnI

100-15000pg/ml

0.1-50ng/mlS/P/W.B

300pg/mL

0.1ng/ml 15minHeart failure;

Acute coronary syndrome

New technology Immunofluorescence Assay

Portability Small in size and light in weight

Suitable for use in various occasion

Ease of use Print results automatically

User friendly

Easy to operate

Multifunction Wide broad spectral of detection

High specificity and high sensitivity

Connectivity PC/LIS/HIS connectivity

Getein1100Immunouorescence Quantitative Analyzer

Performance Characteristics

Getein1100 Parameters

0706


Reaction TimeSampleCat.# Cut-off

ValueTest Item

Test Cards

IF 1012 CK-MB

/cTnIMyocardial injury

2.5~80.0ng/ml0.1~50.0ng/ml

15minS/P/W.B5ng/ml

0.1ng/ml

Qualitative Products

0908

Test Items/Test Cards Quality control (QC) is a procedure

or set of procedures intended to

ensure that a manufactured product

or performed service adheres to a

defined set of quality criteria or

meets the requirements of the client

or customer.

Controls

Product Name Levels Storage Format

QC 001

QC 002

QC 003

QC 004

QC 005

QC 006

QC 007

QC 008

QC 009

QC 010

QC 011

QC 012

Troponin I Control

CK-MB Control

MYO Control

PCT Control

hs-CRP Control

D-Dimer Control

NT-proBNP Control

Cystatin C Control

β 2-MG Control

NGAL Control

mAlb Control

H-FABP Control

1, 2 and 3

1, 2 and 3

1, 2 and 3

1, 2 and 3

1, 2 and 3

1, 2 and 3

1, 2 and 3

1, 2 and 3

1, 2 and 3

1, 2 and 3

1, 2 and 3

1, 2 and 3

Dry Powder

Dry Powder

Dry Powder

Dry Powder

Dry Powder

Dry Powder

Dry Powder

Dry Powder

Dry Powder

Dry Powder

Dry Powder

Dry Powder

Specications

CK-MB

hs-CRP

NT-proBNP

cTnI

CK-MB/cTnI/Myo

PCT

C

T

ID

S

CK-M

B/cTnI/Myo

C

T

ID

S

CK-M

B

C

T

ID

S

NT-p

roBNP

C

T

ID

S

PCT

C

T

ID

S

hs-C

RP

C

T

ID

S

cTnI

Standard Colorimetric Cards

Cat.#

Asia

Nanjing

Europe

Africa

North America

South America

Venezuela Chile Peru

Dominica Canda

France GermanyAustria Britain

HungaryLithuania

LatviaGreeceNorway

AsiaVietnam

ParkistanUAE

UzbekistanBangladesh

IranPhilippines

Saudi ArabiaJordanKorea

libyaBotswana

Zambia Egypt

MozambiqueGhanaNigeria

Partners

Exhibitions

10

7.MEDICAL FAIR ASIA

4.MEDICAL FAIR THAILAND

5.West African Health 8.FIME

2.AFRICA HEALTH1.ARAB HEALTH(Dubai)

6.MEDIC WEST AFRICA

3.MEDICA

12.AACC

CMEF China Intermational

Medical Equipment Fair

9.CMEF

EURASIA

10.Hospitalar 11.expo MED

Certificates

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CerticatesCerticates

*OEM/ODM service for all products are availble.

Documents

POCT catalogue