One Step rapid test kit for detection of HIV 1 & 2 / Syphilis Ab - India CDSCO Medical Device Registration

One Step rapid test kit for detection of HIV 1 & 2 / Syphilis Ab is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000005_26ddb260d205feeb96633fce5535f4b9_bff8006890a53c4552831705fa9ccd36. 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.

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CDSCO Registered

Class Class D

One Step rapid test kit for detection of HIV 1 & 2 / Syphilis Ab

UID: MFG/MD/2018/000005_26ddb260d205feeb96633fce5535f4b9_bff8006890a53c4552831705fa9ccd36

Brand Name

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

License Holder

SD Biosensor Healthcare Pvt. Ltd

Device Class

Class D

Approving Authority

Sub Zonal Baddi

Product Information

It is a rapid chromatographic immunoassay for the qualitative detection of antibodies specific to HIV-1 including subtype 0, HIV-2 and Syphilis (Standard Q HIV 1/2 Ab 4-line ,Ultra HIV 1/2 Ab 4-line) in human serum, plasma or whole blood. The test is for in vitro diagnostic use and Intended as an aid to detect antibodies to HIV-1 /2 and syphilis in Individuals at risk for HIV-1/2 and syphilis infection