HCV Ab FIA Test - India CDSCO Medical Device Registration

HCV Ab FIA Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_152a15adbbd28760f69404c573739b0a_384c2065e8a5095af68714dd28cb5da3. This device is marketed under the brand name PathoCatchTM. The license holder is Mylab Discovery S0lutions 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 Ab FIA Test

UID: MFG/IVD/2020/000021_152a15adbbd28760f69404c573739b0a_384c2065e8a5095af68714dd28cb5da3

Brand Name

PathoCatchTM

License Holder

Mylab Discovery S0lutions Pvt. Ltd

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

HCV Ab FIA Test is a fluorescent immunoassay for the detection of Hepatitis C virus (PathoCatchTM) antibodies in human serum, plasma and whole blood. This test kit is for in vitro diagnostic professional use and is intended as an aid to the early detection of the Hepatitis C virus, and provides only an initial screening test result. More specific alternative diagnosis methods should be performed to obtain confirmation of the Hepatitis C virus (PathoCatchTM)