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 Name: Finecare™ FSH Rapid Quantitative Test
Catalog No: W245
LOT. NO.： F24516201AD
EXP. ： 2024/09/06

Characterization: FSH is the core hormone in the reproductive process of mammal. FSH and
LH cooperatively regulate the physiological process such as development
and reproduction. Basal FSH reflects the secretory function of ovary. FSH
Rapid Quantitative Test Cartridge adopts fluorescence immunoassay
technology and is intended for in vitro quantitative measurement of
follicle-stimulating hormone (FSH) in human whole blood, serum or plasma.

Performance: When sample is added into the sample well of the test, the
fluorescence-labeled detector, FSH antibody binds to FSH antigen in blood
specimen. As the sample mixture migrates on the nitrocellulose matrix of
test strip by capillary action, the complexes of detector antibody of FSH are
captured to FSH antibody that has been immobilized on test strip. Thus the
more FSH antigen is in blood specimen, the more complexes are
accumulated on test strip. Signal intensity of fluorescence of detector
antibody reflects amount of FSH. The default results unit of FSH Rapid
Quantitative Test is displayed as XXX mIU/mL from Finecare™ 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.