Identity
- Trade Name
- VioOne™ HIV Profile™ Supplemental Assay FDA UDI
- Generic Name
- HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 400024 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 400024 FDA UDI
- Primary DI / UDI-DI
- 00853214004001 FDA UDI
- GMDN Term
- HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)
VioOne™ HIV Profile™ Supplemental Assay by AVIOQ, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA).
- GS — Bio-Rad Laboratories · Class II
- GS — Bio-Rad Laboratories · Class II
- GS — Bio-Rad Laboratories · Class II
- VioOne™ HIV Profile™ Supplemental Assay — AVIOQ, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AVIOQ, Inc.
Sources (1)
- FDA UDI 17083641-206e-4368-9713-1644ac606bd0 36 fields · synced Jun 8, 2026