Immunofluorescence Blood D-Dimer Rapid Detection Kit
1. INTEDED USE
This kit is applicable to the in vitro quantitative determination of D-dimer (D-D) in human plasma/whole blood samples and is mainly used for implementing auxiliary diagnosis of venous thrombus and disseminated intravascular coagulation as well as monitor thrombolytic therapy. This kit only provides test result of D-dimer (D-D). The obtained result should be analyzed in combination with other clinical information.
2. PRODUCT SPECIFICATION
| Model No. | D-Dimer |
| Methodology | Fluorescence Immunochromatographic Assay |
| Sample Type | 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 through collecting 148 clinical samples. Use a corresponding marketed immunoturbidimetry kit as the control reagent, and compare the test results Their comparability is studied by linear regression. The correlation coefficients of the two tests are Y=1.014X-0.002 and R=0.9859, respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
