HIV-Ab/Ag 4th Gen - India CDSCO Medical Device Registration

HIV-Ab/Ag 4th Gen is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000065_4d57f33512e406fa6ecf5f3d3836e40d_fff2c956a9ddd519d5d4349becf29ba0. This device is marketed under the brand name Q-LISA. The license holder is Q-Line Biotech Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered

Class Class C

HIV-Ab/Ag 4th Gen

UID: MFG/IVD/2020/000065_4d57f33512e406fa6ecf5f3d3836e40d_fff2c956a9ddd519d5d4349becf29ba0

Brand Name

Q-LISA

License Holder

Q-Line Biotech Private Limited

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

The Q-Line® Rapid HIV-Ab/Ag 4th Gen Rapid Test is a lateral flow immunoassay for the qualitative detection of antibodies to HIV-1 and HIV-2 virus and HIV-1 p24 antigen in human serum, plasma, Whole Blood. It is intended to be used by professionals as a screening test and as an aid in the diagnosis of infection with HIV