Quantitive FSH Follicle-Stimulating Hormone Reagent test kit
1. INTEDED USE
This kit is intended for in vitro quantitative detection on the content of follicle-stimulating hormone (FSH) in the human serum/plasma/blood samples and is intended for assisting in judging the occurrence of female climacteric period. This kit only provides the test result of follicle-stimulating hormone (FSH), and the obtained result shall be analyzed in combination with other clinical information.
2. PRODUCT SPECIFICATION
| Model No. | FSH |
| Methodology | Fluorescence Immunochromatographic Assay |
| Sample Type | Serum/Plasma/Whole blood |
| Time to Result | 10-15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485,CE,MHRA |
| MAIN KIT COMPONENTS
* Test device * Sample diluents * Disposable pipette * Instructions for Use |
PACKING
* 25 test /kit * Aluminum foil bag labeling * shrink wrap |
3.TEST METHOD
4.CLINICAL PERFORMANCE
Clinical evaluation performance of the product is assessed through collecting 150 clinical samples. The results are compared by using the corresponding kit of marketed chemiluminescence method as the reference reagent. Their comparability is studied by linear regression. The correlation coefficients of the two tests are Y=1.039X-0.393 and R=0.9788, respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
