David CE 510K Approval OEM One Step Home Use urine HCG Pregnancy Test Strip

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Product Overview

Description


HCG Pregnancy Test


 






















































Product name



HCG Pregnancy test



Sensitivity



10 miu/ml;15miu/ml;25miu/ml



Accuracy



more than 99%



Shelf time



24-36 month



OEM time



15-35 days



Certificate



CE/ISO13485/510k



Specimen



Urine,Serum



Format



Strip /Cassette /Midstream



Size



Strip: 2.5mm/3.0mm/3.5mm/4.0mm/5mm



 



Cassette :3mm/4.2mm



 



Midstream:4mm/6mm



Usage



Read results within 10-15 minutes



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01.jpgHCG cassette 4.2mm-03


 


_04_01RH-HCG-S


 


HCG.png


 


 


 


RH-HCG-C


HCG


 


 


 


RH-HCG-M


HCG


How to read the results


* Negative: Only one red line appears on the control region. No apparent line on the test region. There is no pregnancy.


* Positive: Distinct red lines appear on the control and test regions. Both test line and control lines indicate that you are pregnancy. Color intensity of the test lines may vary. Different stages of the pregnancy have different concentration of HCG level.


* Invalid: No visible line at all. Repeat test with a new test strip.


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