FDA UDI
In Commercial Distribution
🇺🇸 United States
Avioq HIV-I Microelisa System
DI: 00853214004155
·
Model: 109600
·
Avioq, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Avioq HIV-I Microelisa System
- Primary DI
- 00853214004155
- Version / Model
- 109600
- Catalog Number
- 109600
- Company Name
- Avioq, Inc.
- Labeler DUNS
- 195645259
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 7aa8eb9a-1a8b-4788-b7cb-8bd0defbe777
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| 48480 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853214004155 | GS1 |
Customer Contacts
- Phone
- 919-314-5535
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius