FDA UDI
In Commercial Distribution
🇺🇸 United States
Sentosa SQ Virus Testing Solutions (4x24)
DI: 08885013956559
·
Model: 300732
·
VELA OPERATIONS SINGAPORE PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sentosa SQ Virus Testing Solutions (4x24)
- Primary DI
- 08885013956559
- Version / Model
- 300732
- Catalog Number
- 300732
- Company Name
- VELA OPERATIONS SINGAPORE PTE. LTD.
- Labeler DUNS
- 595361724
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-18
- Public Version
- 1
- Public Version Date
- 2021-01-26
- Public Version Status
- New
- Public Device Record Key
- 01494bcb-69db-4580-9f40-0eda29073d53
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QIC | Hiv-1 Genotyping Assay Using Ngs Technology | Medical Genetics | 866.3955 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08885013956559 | GS1 |