VELA OPERATIONS SINGAPORE PTE. LTD.

Address:50 Science Park Road,Singapore Central Singapore,SG

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Device Description : The Sentosa SQ HIV-1 Genotyping Assay is a next generation sequencing (NGS)-base 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 genomicmutations (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).

Device Class : 2

Duns Number: 595361724

Premarket Exempt : No

Product Code : QIC

Prescription Use : No

Device Count : 1

Device Description : The Sentosa SQ HIV-1 Genotyping Assay is a next generation sequencing (NGS)-base 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 genomicmutations (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).

Device Class : 2

Duns Number: 595361724

Premarket Exempt : No

Product Code : QIC

Prescription Use : No

Device Count : 1

Device Description : The Sentosa SQ HIV-1 Genotyping Assay is a next generation sequencing (NGS)-base 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 genomicmutations (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).

Device Class : 2

Duns Number: 595361724

Premarket Exempt : No

Product Code : QIC

Prescription Use : No

Device Count : 1

Device Description : The Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) is used for magnetic bea The Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) is used for magnetic beads-based nucleic acid extraction from virus in biological specimens. The kit is intended for in vitro diagnostic use.

Device Class : 1

Duns Number: 595361724

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

Device Description : The Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) is used for magnetic bea The Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) is used for magnetic beads-based nucleic acid extraction from virus in biological specimens. The kit is intended for in vitro diagnostic use.

Device Class : 1

Duns Number: 595361724

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

Device Description : The ViroKey™ SX Virus Total Nucleic Acid Kit is used for magnetic beads-based nu The ViroKey™ SX Virus Total Nucleic Acid Kit is used for magnetic beads-based nucleic acid extraction from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples in conjunction with the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 on the Sentosa® SX101 instrument.

Device Class : 1

Duns Number: 595361724

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

Device Description : The ViroKey® HT Virus Total Nucleic Acid Kit (4x96) is used for magnetic beads-b The ViroKey® HT Virus Total Nucleic Acid Kit (4x96) is used for magnetic beads-based nucleic acid extraction from virus in biological specimens.

Device Class :

Duns Number: 595361724

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1