Glycosylated Hemoglobin Hba1c Diagnostic Kits/ Quantitative Result with Ngsp Certificate

• Classification: Biological Diagnostics
• Type: Poct Reagent
• Certification: CE, ISO13485
• Group: All Men
• Sample: Plasma/Serum/Whole Blood
• Method: Immunofluorescence Assay
• Model NO.: HbA1c Fast Test Kit
• Test Time: 5 Min
• Shelf Life: 2 Years
• Transport Package: Carton
• Specification: 25 test/box
• Trademark: GP
• Origin: Jiangsu
• HS Code: 3002190090

Product Description

Basic information
The One Step Test for HbA1c (colloidal gold) is intended for use together with the FIA8000 Quantitative Immunoassay Analyzer (FIA8000). The product employs colloidal gold immunochromatogrphy to determine HbA1c in human whole blood specimens. Two monoclonal antibodies are employed to identify HbA1c 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 HbA1c. 
Then insert test card into the FIA8000 Quantitative Immunoassay Analyzer, the concentration of HbA1c is measured quantitatively and displayed on the screen. The result can be transmitted to the lab or hospital information system. 
Products Code: CG 1017 
Detection Method: colloidal gold, a quantitative test for use with the FIA8000 Quantitative Immunoassay Analyzer.  
Detection Range: 2~14% 
Expected Range of Value:  3.8~5.8% 
Sample Type: whole blood in Heparin/Sodium Citrate/EDTA. 
Reaction Time: yields results in about 3 minutes. 
Storage Temperature: 4-30°C 
Self Time: 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
Sample diluent	25

 
This test is used as an aid for monitoring glycemic control in diabetics. In addition, it can identify people at risk of developing the disease and ongoing monitoring.

Any questions or interests, please contact us.

 
Website:http://getein001.en.made-in-china.com
Add:No.9 Bofu Road,Luhe Distric, Nanjing,211505,China
Postal:211505

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.
 

Product Description

Intended Use

HbA1c fast test kit is intended for the quantitative measurement of HbA1c in human whole blood samples. This test is used as an aid for monitoring glycemic control in diabetics. In addition, it can identify people at risk of developing the disease and ongoing monitoring.

 

About HbA1c

Hemoglobin is the protein molecule in red blood cells with the main function transport oxygen and carbon dioxide in blood. HbA1c belongs to the glycated hemoglobin, a fraction formed by the attachment of various sugars to the Hb molecule and is proportional to average blood glucose concentration over the previous four weeks to three months. One advantage of using HbA1c for diagnosis is that the test does not require a fasting blood sample. Although HbA1c testing is mainly used for monitoring blood sugar control in patients with diabetes, the World Health Organization (WHO) now recommends that HbA1c can be used as a diagnostic test for diabetes, provided that stringent quality assurance tests are in place and assays are standardised to criteria aligned to the international reference values.
 

Contents

1. For Getein1100/Getein1180

Package specifications: 25 tests/box, 10 tests/box

1) HbA1c test card in a sealed pouch with desiccant

2) Capillary pipet

3) Sample diluent

4) User manual: 1 piece/box

5) SD card: 1 piece/box

2. For Getein1600

Package specifications: 2×24 tests/kit, 2×48 tests/kit

1) Sealed cartridge with 24/48 Getein HbA1c test cards

2) User manual: 1 piece/box

Materials required for Getein1600:

1) Sample diluent: 1 bottle/box

2) Box with pipette tips: 96 tips/box

3) Mixing plate: 1 piece/box

Detailed Photos