BioTeke Corporation(wuxi) Co.,Ltd

BioTekeUrine HCG Rapid Test Kit

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This product uses double antibody sandwich immunochromatography technology to achieve in vitro qualitative detection of HCG in Human urine,which is not used for the detection of trophoblastic tumors.
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A.Intended Use:
This product uses double antibody sandwich immunochromatography technology to achieve in vitro qualitative detection of HCG in Human urine,which is not used for the detection of trophoblastic tumors.


B.Product Details :
a. Test Specimen :Urine
b. Sensitivity :100%
c. Accuracy : 99.24%
d. Specificity:96.88%
e. Reading Time : 5-10 min

C.Materials Provided :

Components: Test Card ,Small Straw , Urine Test Cup and Instruction Manual.


D.Advantages :

a.Obtained CE certification;

b.High sensitivity to detect pregnancy earlier;

c.Urine cups and droppers are used with the test card, which is convenient and does not dirty hands;

d.Good specificity, accurate and reliable results;

e.Compact package, easy to carry, reagent card is light and easy to save.

f.The product is easy to operate, economical and practical;

g.Convenient sampling, rapid detection, results without waiting.

h.The results are easy to read at a glance.

E. Product Qualifications(By Jan.2nd,2023)

CE Certification - AEMPS Registration Letter
CE Certification - AEMPS Registration Prove
CE Certification - EC Declaration of Conformity
CE Certification - EAR Certificate of Notification
ISO 13485 Certificate
ISO 9001 Certificate
ISO 45001 Certificate
ISO 14001 Certificate
IPMS Certificate