Determine HIV Early Detect
- UID
- IMP/IVD/2019/000262_5cf6bb4d89017667d2a45201f511667e_82e727c5b5ea46de6d1358f89de70312
- Device class
- Class D
- Brand name
- Determine HIV Controls
- License holder
- Abbott Diagnostics Medical Private Limited
- 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.
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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