HCV ELISA Kit - India CDSCO Medical Device Registration
HCV ELISA Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000123_21b9a4269014e1f3082231a356c1e8fe_f277e28107ce4fbc9b00fdf11954e05a. This device is marketed under the brand name Prolisa. 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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Brand Name
Prolisa
License Holder
Promea Therapeutics Private LimitedDevice Class
Approving Authority
CDSCO, Zonal office, Hyderabad
Product Information
The intended use of Prolisa HCV ELISA kit is to screen blood donors and/or as an aid in diagnosis of clinical conditions related to infection with HCV in human serum or plasma
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