HCV Rapid - India CDSCO Medical Device Registration
HCV Rapid is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000045_566169e677bc6726f42837c7514700e9_b493c55b24d587b8566c1981cbcca6be. The license holder is Promea Therapeutics Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO, Zonal office, Hyderabad.
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License Holder
Promea Therapeutics Private LimitedDevice Class
Approving Authority
CDSCO, Zonal office, Hyderabad
Product Information
The HCV Rapid Test is a double antigen lateral flow chromatographic immunoassay for the qualitative detection of antihepatitis C virus antibodies ##PLACEHOLDER_0## in human serum/plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HCV.
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