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Sentosa SQ HIV-1 Positive Control Kit (96)

FDA UDI

Class II (US FDA UDI)

by Vela Operations Singapore Pte. Ltd.

Identity

Trade Name
Sentosa SQ HIV-1 Positive Control Kit (96) FDA UDI
Generic Name
HIV1 genotyping IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
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). FDA UDI
Model / Reference
300729 FDA UDI
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). FDA UDI

Identifiers

Catalog Number
300729 FDA UDI
Primary DI / UDI-DI
08885013956566 FDA UDI
FDA Product Code
QIC FDA UDI
GMDN Term
HIV1 genotyping IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3955 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Sentosa SQ HIV-1 Positive Control Kit (96) by Vela Operations Singapore Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as HIV1 genotyping IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vela Operations Singapore Pte. Ltd.

Sources (1)

  • FDA UDI 4b3ca9f8-9c7a-4e82-8039-219719fea563 34 fields · synced May 30, 2026