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HBsAg ELISA Kit - India CDSCO Medical Device Registration

HBsAg ELISA Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000123_f3f23a888627c4d3ca02f0f5e0c95fd8_5178a188c59e48f1f92a2fd1a77c352e. 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
HBsAg ELISA Kit
UID: MFG/IVD/2021/000123_f3f23a888627c4d3ca02f0f5e0c95fd8_5178a188c59e48f1f92a2fd1a77c352e

Brand Name

Prolisa

Device Class

Class D

Approving Authority

CDSCO, Zonal office, Hyderabad

Product Information

Prolisa HBsAg ELISA is intended to detect the presence of HBV surface antigen in human serum and plasma of both HBV ad and ay strain

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