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COVID 19 IgG ELISA - India CDSCO Medical Device Registration

COVID 19 IgG ELISA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000019_fd504a975135262194e4558b5e8e248c_4b5b95b1cd609ce1d89b8d00821adfae. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class D
COVID 19 IgG ELISA
UID: MFG/IVD/2021/000019_fd504a975135262194e4558b5e8e248c_4b5b95b1cd609ce1d89b8d00821adfae

Brand Name

Prolisa

Device Class

Class D

Approving Authority

CDSCO, Zonal office, Hyderabad

Product Information

Prolisa Covid-19 IgG ELISA is an in vitro enzyme immunoassay for the qualitative determination of human anti-COVID-19 IgG antibody in human serum and plasma.

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