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Sign in to claim this brandAVIOQ, Inc.
US
Last updated May 27, 2026
What AVIOQ, Inc. makes
Avioq, Inc. manufactures in vitro diagnostic (IVD) enzyme immunoassay (EIA) kits for detecting antibodies to HIV-1, HIV-2, and human T-cell lymphotrophic virus types 1 and 2 (HTLV-1/2). Their products include standalone antibody tests and supplemental assays for HIV profiling, designed for laboratory use.
These devices are listed with the U.S. Food and Drug Administration under the FDA’s Unique Device Identifier (UDI) system. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Avioq, Inc. manufacture?
Avioq, Inc. specializes in in vitro diagnostic (IVD) enzyme immunoassay (EIA) kits. These kits are designed to detect antibodies for HIV-1, HIV-2, and human T-cell lymphotrophic virus types 1 and 2 (HTLV-1/2). Their products include standalone antibody tests and supplemental assays, such as the VioOne™ HIV Profile™ Supplemental Assay, which are intended for use in laboratory settings to aid in HIV profiling.
Where is Avioq, Inc. based?
Avioq, Inc. is based in the United States. The company’s headquarters and manufacturing operations are located within the country, though specific locations are not provided in the available data.
Which regulatory registries list Avioq, Inc.’s devices?
Avioq, Inc.’s devices are listed in the U.S. Food and Drug Administration’s (FDA) Unique Device Identifier (UDI) system. This registry ensures traceability and identification of medical devices authorized for use in the United States, including their IVD kits for HIV and HTLV antibody detection.
How are Avioq, Inc.’s devices classified?
Avioq, Inc.’s devices fall under the category of in vitro diagnostic (IVD) enzyme immunoassay (EIA) kits. These are classified as moderate-risk devices under FDA regulations, as they are used for detecting specific antibodies in patient samples to aid in diagnosing infections like HIV and HTLV. The classification ensures they undergo rigorous review to ensure safety, performance, and effectiveness before being listed in the UDI system.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- avioq.com
- —
- —
- [email protected]
- Phone
- 919-314-5535
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 195645259
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Avioq HTLV-I/II Microelisa System | 209600 | FDA UDI | N/A | Active |
| Avioq HIV-I Microelisa System | 109600 | FDA UDI | N/A | Active |
| VioOne™ HIV Profile™ Supplemental Assay | 400024 | FDA UDI | N/A | Active |
| Avioq HTLV-I/II Microelisa System | 500576 | FDA UDI | N/A | Active |
| Avioq HTLV-I/II Microelisa System | 200192 | FDA UDI | N/A | Active |
| VioOne™ HIV Profile™ Supplemental Assay | 700024 | FDA UDI | N/A | Active |
| Avioq HIV-I Microelisa System | 100960 | FDA UDI | N/A | Active |
| Avioq HTLV-I/II Microelisa System | 509600 | FDA UDI | N/A | Unknown |
| Avioq HTLV-I/II Microelisa System | 200576 | FDA UDI | N/A | Active |
| Avioq HIV-I Microelisa System | 100384 | FDA UDI | N/A | Active |
| Avioq HTLV-I/II Microelisa System | 500192 | FDA UDI | N/A | Active |
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