Determine HIV Early Detect - India CDSCO Medical Device Registration

Determine HIV Early Detect is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000262_5cf6bb4d89017667d2a45201f511667e_82e727c5b5ea46de6d1358f89de70312. This device is marketed under the brand name Determine HIV Controls. The license holder is Abbott Diagnostics Medical Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Determine HIV Early Detect

UID: IMP/IVD/2019/000262_5cf6bb4d89017667d2a45201f511667e_82e727c5b5ea46de6d1358f89de70312

Brand Name

Determine HIV Controls

License Holder

Abbott Diagnostics Medical Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

Determine™ HIV Early Detect is an in vitro, visually read, qualitative immunoassay for the detection of antibodies (Determine HIV Controls) to HIV-1 and HIV-2 and the detection of non-immunocomplexed (Determine HIV Controls) HIV-1 p24 antigen (Determine HIV Controls) in human capillary and venous whole blood, plasma or serum.