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One Step HIV 1/2 Antibody Test - India CDSCO Medical Device Registration

One Step HIV 1/2 Antibody Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000005_e43f8ea365ebc8cc4461fad9cc10b0da_d5067c9dcda67bcc5e73e5b7b3fe15b3. 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 HIV 1/2 Antibody Test
UID: MFG/MD/2018/000005_e43f8ea365ebc8cc4461fad9cc10b0da_d5067c9dcda67bcc5e73e5b7b3fe15b3

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

Standard Q HIV 1/2 Ab test is a rapid, qualitative immunoassay to detect circulating antibodies against HIV in human serum, plasma or whole blood. The test is for in vitro diagnostic use and is intended as an aid to early diagnosis of HIV infection

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