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HBsAg Rapid Kit - India CDSCO Medical Device Registration

HBsAg Rapid Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000045_d02f478aae1c7e1348eafd50c5713463_ebab920d1f737e46e7ed31ca117506f0. This device is marketed under the brand name IgG and IgM. 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
HBsAg Rapid Kit
UID: MFG/IVD/2022/000045_d02f478aae1c7e1348eafd50c5713463_ebab920d1f737e46e7ed31ca117506f0

Brand Name

IgG and IgM

Device Class

Class D

Approving Authority

CDSCO, Zonal office, Hyderabad

Product Information

Proflow HBsAg Rapid Kit is intended to be used as an aid in the recognition and diagnosis of acute infections and chronic infectious carriers of the Hepatitis B Virus

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