Uncut sheet for FSH Rapid test
1. INTEDED USE
The FSH Rapid Test Device (the "uncut sheet" format for manufacturing use) is intended for the qualitative detection of follicle-stimulating hormone (FSH) in human urine specimens.
This test is intended for in vitro diagnostic professional use and serves as an aid in the assessment of female reproductive health, including the evaluation of perimenopause, menopause, and ovarian function .
FSH is a glycoprotein hormone secreted by the anterior pituitary gland. In women, FSH promotes the growth and maturation of ovarian follicles, and its levels increase significantly during perimenopause and after menopause . The test employs a double antibody sandwich immunochromatographic assay using colloidal gold conjugation to capture FSH present in the specimen .
Eesults obtained shall be used in combination with other clinical information for analysis.
This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.
2. PRODUCT SPECIFICATION
| Model No. | FSH Uncut sheet |
| Methodology | Colloidal Gold |
| Sample Type | Faces |
| Time to Result | 15~20mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 | Remove test device from aluminum foil pouch, lie it on a horizontal workbench, and do a good job in marking. |
| 2 | Use disposable pipette to pipette urine sample in disposable clean container, discard first two drops of urine, add 3 drops (approx. 100μL) of bubble-free urine sample dropwise to well of test device vertically and slowly, and start counting time. |
| 3 | Interpret result within 10-15 minutes, and detection result is invalid after 15 minutes (see detailed results in result interpretation). |
4.RESULT EVALUATION AND EXPLANATION
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
6.EXHIBITION
