FDA 510K Digital Pregnancy Rapid Test from Manufacturer
Product purpose
MissLan Digital Pregnancy Rapid Test is intended for the
qualitative detectionof human chorionic gonadotropin (hCG) in
urine, as an aid in early detection ofpregnancy. lt is intended for
use by people who would like to find out whetherthey are pregnant
in a home environment.
Only for use outside the body. For over the counter use.
Components
1. One pouch containing a test and a bag of desiccant.
2. Leaflet with instructions for use.
Materials needed but not provided: A urine collection cup to
collect the urine.
Test method and result
Certificates
Company profile
As a high-tech manufacturer of IVD products, DoChek was founded in
2018, honored as an innovative, high-tech, specialized enterprise.
We own professional R&D, manufacture, quality management,
design and sales teams. Our products cover fertility, tumor, drug
of abuse tests and etc., most of which are CE, FDA, TGA and HSA
approved. We’ve established a complete QMS system by passing
ISO9001, ISO13485, MDSAP, BRC and BSCI.
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