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HbA1c Rapid Quantitative Test COA - F20718B03AD

This certificate of analysis provides information on a HbA1c rapid quantitative test by Wondfo Biotech. The test uses fluorescence immunoassay technology to quantitatively determine HbA1c levels in human whole blood. After mixing the sample and buffer, the sample is added to the test cartridge where fluorescence-labeled antibodies bind to HbA1c and Hb. The ratio of fluorescent signals for HbA1c and Hb determines the HbA1c level displayed as a percentage. The test has a 24-month expiry date and should be stored between 4-30°C.

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223 views1 page

HbA1c Rapid Quantitative Test COA - F20718B03AD

This certificate of analysis provides information on a HbA1c rapid quantitative test by Wondfo Biotech. The test uses fluorescence immunoassay technology to quantitatively determine HbA1c levels in human whole blood. After mixing the sample and buffer, the sample is added to the test cartridge where fluorescence-labeled antibodies bind to HbA1c and Hb. The ratio of fluorescent signals for HbA1c and Hb determines the HbA1c level displayed as a percentage. The test has a 24-month expiry date and should be stored between 4-30°C.

Uploaded by

g64bt8rqdw
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Guangzhou Wondfo Biotech Co., Ltd.

No. 8 Lizhishan Road, Science City, Luogang District, 510663,


Guangzhou, P.R. China
Tel: 86-20-32296083 Fax: 86-20-32296063
Website: en.wondfo.com.cn E-mail: Finecare@wondfo.com.cn

CERTIFICATE OF ANALYSIS
PRODUCT: FinecareTM HbA1c Rapid Quantitative Test
Catalog No: W207
LOT. NO.： F20718B03AD
EXP. ： 2025/04/13

Characterization: Glycated hemoglobin (HbA1c) is a glycated form of hemoglobin that is


measured primarily to identify the average plasma glucose concentration
over prolonged periods of time. HbA1c Rapid Quantitative Test Cartridge
adopts fluorescence immunoassay technology and is intended for in vitro
quantitative determination of HbA1c in human whole blood.

Performance: After mixing with sample and buffer, sample mixture is added to the sample
well of the Test Cartridge, the fluorescence-labeled detector HbA1c
antibody binds to HbA1c in blood specimen. As the sample mixture
migrates on the nitrocellulose matrix of test strip by capillary action, the
complexes of detector antibody and HbA1c are captured to HbA1c antibody
that has been immobilized on test strip. The fluorescence-labeled detector
Hb antibody binds to Hb in blood specimen; the complexes are captured to
Hb antibody that has been immobilized on test strip. Signal intensity of
fluorescence is proportional to concentrations of HbA1c and Hb in blood
specimen. The ratio between inflorescent signals of HbA1c and Hb is the
ratio between HbA1c and Hb. The default results unit of HbA1c Test is
displayed as XX % from FinecareTM FIA Meter.

Package: Packaging procedure strictly follows the production manual and packaging
control is carried out by the quality control system. Inner package: Sealed
pouch contains 1 test. Outer package: kit size of outer package is variable.

Expiry: The device is stable for 24 months from the manufactured date.

Storage: The buffer and test cartridge should be stored at temperature of 4～30℃.

Precaution: The product is offered without warranty for any other specific use than that
specified in the instruction of use.
Product approved and released based on information gained from manufacturer by:

Quality Manager
Guangzhou Wondfo Biotech Co., Ltd.

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