Identity
- Trade Name
- Avioq HTLV-I/II Microelisa System FDA UDI
- Generic Name
- Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Avioq HTLV-I/II Microelisa System is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of antibodies to Human T-Lymphotropic Virus Type I (HTLV-I) and/or Human T-Lymphotropic Virus Type II (HTLV-II) in human serum, plasma, and cadaveric specimens. FDA UDI
- Model / Reference
- 500576 FDA UDI
- Description
- Avioq HTLV-I/II Microelisa System is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of antibodies to Human T-Lymphotropic Virus Type I (HTLV-I) and/or Human T-Lymphotropic Virus Type II (HTLV-II) in human serum, plasma, and cadaveric specimens. FDA UDI
Identifiers
- Catalog Number
- 500576 FDA UDI
- Primary DI / UDI-DI
- 00853214004087 FDA UDI
- GMDN Term
- Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) 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
Yes
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: Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, enzyme immunoassay (EIA)
Avioq HTLV-I/II Microelisa System by AVIOQ, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, enzyme immunoassay (EIA).
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 |
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Manufacturer
- Manufacturer
- AVIOQ, Inc.
Sources (1)
- FDA UDI 7647fa45-daca-4e69-b2bd-79c5815aba4e 36 fields · synced May 30, 2026