One Step Dengue NS1 Antigen and Antibodies Test - India CDSCO Medical Device Registration
One Step Dengue NS1 Antigen and Antibodies Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000085_30224046d0781b31ce30668190332876_690fe9ece1c98dd40d9f722d5d1575a3. This device is marketed under the brand name Pratham ®. The license holder is M/s ASTAM DIAGNOSTICS PVT. LTD., and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.
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Brand Name
Pratham ®
License Holder
M/s ASTAM DIAGNOSTICS PVT. LTD.Device Class
Approving Authority
CDSCO -North Zone, Ghaziabad
Product Information
Dengue NS1 Antigen and Antibody IgG & IgM Test Device is a rapid, qualitative immuno-chromatographic test for the detection of Dengue NS-1 (Pratham ®) antigen and differential detection of IgM & IgG antibodies to Dengue virus in human serum/plasma. For professional and in-vitro diagnostic use only
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