HCV Rapid Diagnostic Test Kit - India CDSCO Medical Device Registration

HCV Rapid Diagnostic Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000164_f6ce61f252d070e3a2ffbcc628e2fac0_9b30b5b6ee7d94146bde716073146d39. This device is marketed under the brand name AccuTest HBsAg Rapid Diagnostic Test Kit. The license holder is Accurex Biomedical Pvt Ltd, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class D

HCV Rapid Diagnostic Test Kit

UID: MFG/IVD/2022/000164_f6ce61f252d070e3a2ffbcc628e2fac0_9b30b5b6ee7d94146bde716073146d39

Brand Name

AccuTest HBsAg Rapid Diagnostic Test Kit

License Holder

Accurex Biomedical Pvt Ltd

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

AccuTest HCV IS intended to be used for qualitative detection of antibodies generated against proteins encoded by core, NS3, NS4 & NS5 parts of HCV genome in human serum/plasma