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HBsAg Rapid Test - India CDSCO Medical Device Registration

HBsAg Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000139_d48047f9578cff055c32f1e8aca0818e_ea96ed689157b0a049b5383dcf309c63. The license holder is LABGENE BIO-TECH PRIVATE LIMITED, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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 Test
UID: MFG/IVD/2022/000139_d48047f9578cff055c32f1e8aca0818e_ea96ed689157b0a049b5383dcf309c63

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The HBsAg Rapid test ##PLACEHOLDER_0## kit is a rapid immunochromatography assay for the qualitative detection of the surface antigen of Hepatitis B Virus in human whole blood, serum, or plasma samples

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