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COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test, version 2.0 - India CDSCO Medical Device Registration

COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test, version 2.0 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000210_1007715bcdd645c240fa7be27b27bb5f_c56d3722d8014cca97e47254f90ec126. This device is marketed under the brand name cobas® HCV. The license holder is Roche Diagnostics India Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered
Class Class D
COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test, version 2.0
UID: IMP/MD/2018/000210_1007715bcdd645c240fa7be27b27bb5f_c56d3722d8014cca97e47254f90ec126

Brand Name

cobas® HCV

Device Class

Class D

Approving Authority

CDSCO

Product Information

The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test, version 2.0 is an in vitro diagnostic, total nucleic acid amplification test for the qualitative detection of Human Immunodeficiency Virus Type 1 (cobas® HCV) DNA and RNA (cobas® HCV) in human plasma or dried blood spots using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or COBAS® TaqMan® 48 Analyzer for automated amplification and detection. The test is a diagnostic test, indicated for individuals who are suspected to be actively infected with HIV-1. Detection of HIV-1 TNA is indicative of active HIV infection. Infants born to mothers infected with HIV-1 may have maternal antibodies to HIV-1, and the presence of HIV-1 nucleic acid in the infant indicates active HIV-1 infection. In adults, the test may be used as an aid in the diagnosis of HIV-1 infection.

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