Machine Use LH Luteinizing Hormone Ovulation Rapid Test
1. INTEDED USE
This kit is for in vitro quantitative test on the content of luteinizing hormone (LH) in human serum/plasma/blood sample and is mainly used for evaluating the endocrine function of pituitary gland. This kit only provides the test result of luteinizing hormone (LH), and the obtained result shall be analyzed in combination with other clinical information.
2. PRODUCT SPECIFICATION
| Model No. | LH |
| 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 162 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 = 0.950X + 0.703 and R = 0.9849, respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
