HCV antibody test - India CDSCO Medical Device Registration

HCV antibody test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000085_29c26c0d758cd0d1fe247e6b87355206_6043970755a863ae756075d25fd0f6d8. 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 D. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered

Class Class D

HCV antibody test

UID: MFG/IVD/2021/000085_29c26c0d758cd0d1fe247e6b87355206_6043970755a863ae756075d25fd0f6d8

Brand Name

Pratham

License Holder

M/s ASTAM DIAGNOSTICS PVT. LTD.

Device Class

Class D

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

HCV Test Device is an in vitro diagnostic rapid test based on the principle of immunochromatography test for qualitative detection of hepatitis C virus in human serum/ plasma/ Whole blood. For professional and In-vitro diagnostic use only