Malaria Pan/Pf antigen rapid kit - India CDSCO Medical Device Registration

Malaria Pan/Pf antigen rapid kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000045_35879e72979e5fa7451acfa9a5088a30_4d5c4ca019d683df2d88e3efcb1a9e31. The license holder is Promea Therapeutics Private Limited, and it is classified as Device Class Class C. 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.

Free Database

CDSCO Registered

Class Class C

Malaria Pan/Pf antigen rapid kit

UID: MFG/IVD/2022/000045_35879e72979e5fa7451acfa9a5088a30_4d5c4ca019d683df2d88e3efcb1a9e31

License Holder

Promea Therapeutics Private Limited

Device Class

Class C

Approving Authority

CDSCO, Zonal office, Hyderabad

Product Information

Malaria Pan/Pf Ag Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum ##PLACEHOLDER_0## antigen and P. vivax ##PLACEHOLDER_0##, P. ovale ##PLACEHOLDER_0##, or P. malaria ##PLACEHOLDER_0## antigen in human blood specimen. This device is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with plasmodium