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One Step rapid test for detection of HIV 1 & 2 antibodies - India CDSCO Medical Device Registration

One Step rapid test for detection of HIV 1 & 2 antibodies is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000005_39dc15ed12d57ad09ba6792c7495c615_49b99250a705694351fe7b9868626b4c. This device is marketed under the brand name Standard Q HIV 1/2 Ab 4-line ,Ultra HIV 1/2 Ab 4-line. The license holder is SD Biosensor Healthcare Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is Sub Zonal Baddi.

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 rapid test for detection of HIV 1 & 2 antibodies
UID: MFG/MD/2018/000005_39dc15ed12d57ad09ba6792c7495c615_49b99250a705694351fe7b9868626b4c

Brand Name

Standard Q HIV 1/2 Ab 4-line ,Ultra HIV 1/2 Ab 4-line

Device Class

Class D

Approving Authority

Sub Zonal Baddi

Product Information

It is a rapid, qualitative immunoassay to detect circulating antibodies against HIV in human serum, plasma or whole blood.

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