Avioq HIV-I Microelisa System
- Primary DI
- 00853214004155
- Brand
- Avioq HIV-I Microelisa System
- Company
- Avioq, Inc.
- Model
- 109600
- Catalog number
- 109600
- Device description
- The Avioq HIV-1 Microelisa System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human specimens collected as serum, plasma, dried blood spots, or oral fluid specimens obtained with OraSure®.HIV-1 Oral Specimen Collection Device.
- Published
- 2014-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00853214004155 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00853214004155 | 00853214004155 | 853214004155 | 0853214004155 |
GMDN Terms
| Term | Definition |
|---|
| HIV1 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 antibodies to the human immunodeficiency virus 1 (HIV1) in a clinical specimen, using an enzyme immunoassay (EIA) method. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Temperature | 15 Degrees Celsius | 30 Degrees Celsius | |
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 195645259
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00853214004223 | VioOne™ HIV Profile™ Supplemental Assay | 700024 | 700024 | 2024-05-21 |
| 00853214004018 | Avioq HTLV-I/II Microelisa System | 200192 | 200192 | 2023-05-12 |
| 00853214004025 | Avioq HTLV-I/II Microelisa System | 200576 | 200576 | 2023-05-12 |
| 00853214004032 | Avioq HTLV-I/II Microelisa System | 209600 | 209600 | 2023-05-12 |
| 00853214004001 | VioOne™ HIV Profile™ Supplemental Assay | 400024 | 400024 | 2022-10-18 |
| 00853214004070 | Avioq HTLV-I/II Microelisa System | 500192 | 500192 | 2014-09-24 |
| 00853214004087 | Avioq HTLV-I/II Microelisa System | 500576 | 500576 | 2014-09-24 |
| 00853214004094 | Avioq HTLV-I/II Microelisa System | 509600 | 509600 | 2014-09-24 |
| 00853214004131 | Avioq HIV-I Microelisa System | 100384 | 100384 | 2014-09-24 |
| 00853214004148 | Avioq HIV-I Microelisa System | 100960 | 100960 | 2014-09-24 |
avioq.com