Sentosa SQ HIV Genotyping Assay (4x16)

Primary DI

08885013956610

Basic UDI-DI Code

B-08885013956610

Reference

690037

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List A

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa SQ HIV Genotyping Assay (4x16) is a next generation sequencing-based in vitro diagnostic test intended for the detection of HIV-1 Group M genomic mutations in Protease, Reverse Transcriptase and Integrase regions from plasma in patients diagnosed with HIV infection. This test is intended to be used on the Sentosa SX101 with the Sentosa SX Virus Total Nucleic Acid Plus II Kit (4x16) in conjunction with the Sentosa SQ301 instruments. Results should be used in conjunction with other available laboratory and clinical information and are not intended for use as a stand-alone diagnostic test. The Sentosa SQ HIV Genotyping Assay (4x16) is not indicated for use as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection.

Other on-the-market devices with the same classification (Eu Ivd Annex 2 List A) and regulation (EU IVDD).