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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/2020/000118_8614dd2d7c953609a9d12561a3446705_0249a3f92c6b3fdf9a4abc36b4f24105. This device is marketed under the brand name Device. The license holder is ORCHID BIOMEDICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class D. The approving authority is Sub Zonal Goa.

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/2020/000118_8614dd2d7c953609a9d12561a3446705_0249a3f92c6b3fdf9a4abc36b4f24105

Brand Name

Device

Device Class

Class D

Approving Authority

Sub Zonal Goa

Product Information

Rapid Qualitative Two Site Sandwich Immunassay for the detection of Hepatitis B Surface Antigen , a marker of Hepatitis B infections serum / plasma specimen

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