AccessGUDID - DEVICE: Sentosa SQ HIV-1 Genotyping Reagents (4x24) (08885013956542)

GUDID

Device Identifier (DI) Information

Brand Name: Sentosa SQ HIV-1 Genotyping Reagents (4x24)
Version or Model: 300731
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 300731
Company Name: VELA OPERATIONS SINGAPORE PTE. LTD.

Primary DI Number: 08885013956542
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595361724 *Terms of Use

Device 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).

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48468	HIV1 genotyping IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to determine the genotype of human immunodeficiency virus 1 (HIV1) in a clinical specimen, using a nucleic acid technique (NAT). The genotyping is typically performed to help determine viral resistance to specific antiretroviral drugs (AVRs) during patient treatment planning.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QIC	Hiv-1 Genotyping Assay Using Ngs Technology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c8264998-527f-4888-8ebe-d17946b0ef39
Public Version Date: January 26, 2021
Public Version Number: 1
DI Record Publish Date: January 18, 2021