2. 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 certification and CE certification
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
2002
Founded
762
Employees
2000
GMP Workshop
246
Researchers
Getein was Founded
Founded in Nanjing, 17000 square meters of Getein’s total construction
area and 2,000 square meters GMP workshop.
Team Construction
Focused on the rapid diagnosis scientific research.
Established a professional R&D team.
Domestic Sales
Cardiac test kits became available.
Occupied the domestic market.
ISO Certification and CE Mark
Achieved the Rheinland TÜV ISO 13485:2012 quality management
system certification and CE certification.
Overseas Sales
Started the POCT business in Asia, the Middle East, Africa, lndia and etc.
Expand product lines: POCT, clinical chemistry and raw material.
Expand the market
15000 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
Getein
History
2002
2003-2007
2008-2010
2011
2012-2013
2014-2015
Future
4. Getein1600 Parameters
Performance Characteristics
Fully 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
Time
15min
10min
15min
SampleCat.#
IF 1001
IF 1002
IF 1003
IF 1005
IF 1006
IF 1007
Cut-off
Value
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/ml
0.1~50.0ng/ml
30~600ng/ml
CK-MB
/cTnI
/Myo
Myocardial injury 15minS/P/W.B
5ng/ml
0.1ng/ml
70ng/ml
10min0.5mg/L
0.1ng/mlS/P/W.B
P/W.B
0.1~50ng/mlSepsis;
Septic shock
Getein1600
Immunouorescence 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-proBNPcTnI CK-MB/cTnI/Myo
CK-MB/cTnI/H-FABP
Test Item
IF 1004
NT-proBNP
/cTnI
100-15000pg/ml
0.1-50ng/ml
S/P/W.B
300pg/mL
0.1ng/ml 15min
Heart failure;
Acute coronary
syndrome
CysC
Early diagnosis of
kidney disease;
Detection of kidney
damage for
surgery patients
0.5~10.0mg/L S/P/W.B 0.51~1.09
mg/L
3minIF 1008
IF 1010 NGAL The best indicator
of early renal injury 50~1500ng/ml Urine 135ng/ml 3min
IF 1011 β2-MG
Kidney damage for
diabetic
& hypertensive
patients
0.5~20.0mg/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
5. Micro Printer
cTnI
NT-proBNP
Myocardial
infarction
Cardiovascular
inflammatory
diseases;
Inflammatory
disorders
Venous
thromboembolism;
Pulmonary embolism
0.5~50.0ng/ml
100~35000pg/ml
PCT
Heart failure
D-Dimer 0.1~10.0mg/L
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/L
10mg/L
S/P/W.B
S/P/W.B
90s
2.5~80.0ng/ml
0.5~50.0ng/ml
30~600ng/ml
CK-MB
/cTnI
/Myo
Myocardial injury 15minS/P/W.B
5ng/ml
0.5ng/ml
70ng/ml
7min0.5mg/L
0.1ng/mLS/P/W.B
P/W.B
0.1~50ng/mlSepsis;
Septic shock
CG 1009
CG 1010
CG 1011
CG 1013
CG 1017
CysC
mAlb
NGAL
β2-MG
HCG
HbA1c
Early diagnosis of
kidney disease;
Detection of kidney
damage for
surgery patients
Early diagnosis
and evaluation
of diabetic
nephropathy
The best indicator
of early renal injury
Kidney damage for
diabetic
& hypertensive
patients
Pregnancy early test
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
0.51~1.09
mg/L
20mg/ml
135ng/ml
0.8~3.0
mg/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/ml
S/P/W.B
300pg/mL
0.5ng/ml
18min
CG 1001
FIA8000
Quantitative 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
Disease Measuring
Range
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 1012
CK-MB
/cTnI
Myocardial injury 15minS/P/W.B
5ng/ml
0.5ng/ml
2.5~80.0ng/ml
0.5~50.0ng/ml
6. cTnI
NT-proBNP
Myocardial
infarction
Cardiovascular
inflammatory
diseases;
Inflammatory
disorders
Venous
thromboembolism;
Pulmonary embolism
0.1~50.0ng/ml
100~35000pg/ml
PCT
Heart failure
D-Dimer 0.1~10.0mg/L
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/L
10mg/L
S/P/W.B
S/P/W.B
3min
2.5~80.0ng/ml
0.1~50.0ng/ml
30~600ng/ml
CK-MB
/cTnI
/Myo
Myocardial injury 15minS/P/W.B
5ng/ml
0.1ng/ml
70ng/ml
10min0.5mg/L
0.1ng/mLS/P/W.B
P/W.B
0.1~50ng/mlSepsis;
Septic shock
IF 1009
IF 1010
IF 1011
IF 1013
IF 1017
CysC
mAlb
NGAL
β2-MG
HCG
HbA1c
Early diagnosis of
kidney disease;
Detection of kidney
damage for
surgery patients
Early diagnosis
and evaluation
of diabetic
nephropathy
The best indicator
of early renal injury
Kidney damage for
diabetic
& hypertensive
patients
Pregnancy early test
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
0.51~1.09
mg/L
20mg/ml
135ng/ml
0.8~3.0
mg/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/ml
S/P/W.B
300pg/mL
0.1ng/ml 15min
Heart 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
Getein1100
Immunouorescence Quantitative Analyzer
Performance Characteristics
Getein1100 Parameters
0706
Disease Measuring
Range
Reaction
TimeSampleCat.# Cut-off
ValueTest Item
Test Cards
IF 1012 CK-MB
/cTnI
Myocardial injury
2.5~80.0ng/ml
0.1~50.0ng/ml
15minS/P/W.B
5ng/ml
0.1ng/ml
7. 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
β2-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-MB/cTnI/Myo
C
T
ID
S
CK-MB
C
T
ID
S
NT-proBNP
C
T
ID
S
PCT
C
T
ID
S
hs-CRP
C
T
ID
S
cTnI
Standard Colorimetric Cards
Cat.#
