FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Avioq HTLV-I/II Microelisa System
DI: 00853214004094
·
Model: 509600
·
Avioq, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Avioq HTLV-I/II Microelisa System
- Primary DI
- 00853214004094
- Version / Model
- 509600
- Catalog Number
- 509600
- Company Name
- Avioq, Inc.
- Labeler DUNS
- 195645259
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 3
- Public Version Date
- 2023-05-15
- Public Version Status
- Update
- Public Device Record Key
- f72e3310-f1cb-4349-80f4-2e6e6229c147
- Distribution End Date
- 2023-05-01
Device 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.
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 |
|---|---|---|---|---|
| 48523 | Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) 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 human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2) 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 | 00853214004094 | 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