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Sentosa SQ HIV-1 Positive Control Kit (8)

VELA OPERATIONS SINGAPORE PTE. LTD. · Model 300800 · UDI-DI 08885013956597

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Description

The Sentosa SQ HIV-1 Genotyping Assay is a next generation sequencing (NGS)-based in vitro diagnostic (IVD) test intended for use in detecting HIV-1 genomic mutations (in the protease, reverse transcriptase and integrase regions of the pol gene), as an aid in monitoring and treating HIV-1 infection. This test is used in adjunct to the therapeutic management of patients diagnosed with HIV-1 Group M infection, with viral loads of at least 1,000 RNA copies per mL in EDTA plasma specimens. The Sentosa SQ HIV-1 Genotyping Assay consists of Sentosa SQ HIV-1 Genotyping Reagents and Sentosa SQ Virus Testing Solutions. They are used with the Sentosa SQ HIV-1 Positive Control Kit (96/8).

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.