Malb One Step Test Kit /Renal Marker with Ce

Classification: Biological Diagnostics
Type: Poct
Certification: CE, MSDS, ISO13485
Group: All Men
Suitable Machine: Fia8600/Fia8000
Transport Package: Carton
Customization:

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Basic Info.

Model NO.
CG1009
Specification
25 test /BOX
Trademark
GP
Origin
Jiangsu
HS Code
3002190090

Product Description

 
The One Step Test for mAlb (colloidal gold) is intended for use together with the FIA8000 Quantitative Immunoassay Analyzer (FIA8000). The product employs colloidal gold immunochromatogrphy to determine mAlb in human urine specimen. Polyclonal antibody and recombinant antigen are employed to identify mAlb specifically, resulting in a purplish red streak appears on the test line. The color intensity of the test line increases in proportion to the concentrations of mAlb.
Then insert test card into the FIA8000 Quantitative Immunoassay Analyzer, the concentration of mAlb is measured quantitatively and displayed on the screen. The result can be transmitted to the lab or hospital information system.
 
 
Products Code: CG 1009
Detection Method: colloidal gold, a quantitative test for use with the FIA8000 Quantitative Immunoassay Analyzer. 
Detection Range: 10.0-200.0 mg/L
Cut-off Value: 20.0 mg/L
Sample Type: urine.
Reaction Time: yields results in about 3 minutes.
Storage Temperature: 4-30°C
Storage Life: 24 months. Use the test card within 1 hour once the foil bag is opened.
 
 
Package
A box package contains 25 tests:
 
 
 Foil bag, which contains one test card and one desiccant 25
 Disposable pipet 25
 Manual 1
 SD card 1


Clinical Application
1. Indicator of Diabetic nephropathy, hypertensive nephropathy and early renal damage;
2. An early indicator of changes in renal and cardiovascular system;
3. Detection of Pregnancy-induced renal disease;
4. An important indicator in diagnosing glomerular injury.

Company Profile


Getein Biotech Inc. (stock code: 603387), established in 2002, is a fully integrated in vitro diagnostic company that researches and develops, manufactures, markets and distributes a broad range of innovative diagnostic test kits in point-of-care, clinical chemistry, chemiluminescent assays, and molecular diagnostics. The company sits on a 10.5 square kilometers science park and is equipped with state-of-the-art R&D and production facilities. It also manufactures analytic medical devices and a variety of biological and non-biological raw materials for applications in diagnostics, pharmaceuticals, and academic research.
 

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Manufacturer/Factory & Trading Company
Year of Establishment
2002-03-08
Plant Area
83000 square meters