Determine HIV-1/2 - India CDSCO Medical Device Registration

Determine HIV-1/2 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000262_4e0c8876b1f55082585b3e2987e59d8c_a680f3119338b229719daa8fea3fcf95. 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-1/2

UID: IMP/IVD/2019/000262_4e0c8876b1f55082585b3e2987e59d8c_a680f3119338b229719daa8fea3fcf95

Brand Name

Determine HIV Controls

License Holder

Abbott Diagnostics Medical Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Determine™ HIV-1/2 is an In Vitro, visually read, qualitative immunoassay for the detection of antibodiess to HIV-1 and HIV-2 in human serum, plasma or whole blood. The test is intended as an aid to detect antibodies to HIV-1/HIV-2 from infected individuals. The test is for professional use only