FDA UDI
In Commercial Distribution
🇺🇸 United States
VioOne™ HIV Profile™ Supplemental Assay
DI: 00853214004223
·
Model: 700024
·
AVIOQ, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VioOne™ HIV Profile™ Supplemental Assay
- Primary DI
- 00853214004223
- Version / Model
- 700024
- Catalog Number
- 700024
- Company Name
- AVIOQ, Inc.
- Labeler DUNS
- 195645259
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-21
- Public Version
- 2
- Public Version Date
- 2024-09-30
- Public Version Status
- Update
- Public Device Record Key
- e0ecf577-fff7-4153-a4b8-1a69f6688885
Device Description
The VioOne™ HIV Profile™ Supplemental Assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to Human Immunodeficiency Virus Type 1 (HIV-1 Group M & Group O) and Type 2 (HIV-2) in human serum or plasma.
Device Characteristics
- Single Use
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48445 | HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from and antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853214004223 | GS1 |
Customer Contacts
- Phone
- 919-314-5535
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius