One Step Dengue Antigen NS1 Test - India CDSCO Medical Device Registration
One Step Dengue Antigen NS1 Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000085_b5aaa89ad352b2bbb521a6efc4de0c7b_5f8d4291213db48b42cf03b9a2896d7f. 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
One step dengue Antigen test is a rapid immunoassay based upon chromatography principle for the qualitative detection of NS1 antigen in human specimen to an aid in the diagnosis of infection with Dengue. For professional and in-vitro diagnostic use only
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