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One Step Test for HBsAg - India CDSCO Medical Device Registration

One Step Test for HBsAg is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000130_8614dd2d7c953609a9d12561a3446705_e2b8fe75a9feb3c9e1feb408e5a6fd76. This device is marketed under the brand name Device. The license holder is VIOLA DIAGNOSTIC SYSTEMS - A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED,, and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.

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
One Step Test for HBsAg
UID: MFG/IVD/2020/000130_8614dd2d7c953609a9d12561a3446705_e2b8fe75a9feb3c9e1feb408e5a6fd76

Brand Name

Device

Device Class

Class D

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

VIRUCHECK One Step Test for HBsAg is a Rapid, qualitative, two site sandwich immunoassay for the detection of Hepatitis B Surface Antigen, a marker of Hepatitis B infections in serum/plasma specimens

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