Sentosa SQ Virus Testing Solutions (4x24) 300732

GUDID 08885013956559

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).

VELA OPERATIONS SINGAPORE PTE. LTD.

HIV1 genotyping IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 08885013956559
• NIH Device Record Key: 01494bcb-69db-4580-9f40-0eda29073d53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentosa SQ Virus Testing Solutions (4x24)
• Version Model Number: 300732
• Catalog Number: 300732
• Company DUNS: 595361724
• Company Name: VELA OPERATIONS SINGAPORE PTE. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08885013956559 [Primary]

FDA Product Code

• QIC: Hiv-1 Genotyping Assay Using Ngs Technology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-26
• Device Publish Date: 2021-01-18

Devices Manufactured by VELA OPERATIONS SINGAPORE PTE. LTD.

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