Sentosa SQ Virus Testing Solutions (4x24) - The Sentosa SQ HIV-1 Genotyping Assay is a next - VELA OPERATIONS SINGAPORE PTE. LTD.

Duns Number:595361724

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

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More Product Details

Catalog Number

300732

Brand Name

Sentosa SQ Virus Testing Solutions (4x24)

Version/Model Number

300732

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

QIC

Product Code Name

Hiv-1 Genotyping Assay Using Ngs Technology

Device Record Status

Public Device Record Key

01494bcb-69db-4580-9f40-0eda29073d53

Public Version Date

January 26, 2021

Public Version Number

1

DI Record Publish Date

January 18, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VELA OPERATIONS SINGAPORE PTE. LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 9