CE Approved Blood Tes Testosterone test kit
1. INTEDED USE
This kit is suitable for in vitro quantitative detection of testosterone (Tes) in human serum/plasma/whole blood samples, mainly for evaluating testosterone levels. This kit only provides the test result of Testosterone. The obtained result should be analyzed in combination with other clinical information.
2. PRODUCT SPECIFICATION
| Model No. | Tes |
| 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 * 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 by collecting 193 clinical samples. The results are compared by using the corresponding kit of marketed electrochemiluminescence method as the control reagent. Their comparability is studied by linear regression. The correlation coefficients of the two tests are Y=0.987X+0.009 and R=0.9825, respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
