FDA UDI
In Commercial Distribution
🇺🇸 United States
Alinity
DI: 00380740117214
·
Model: 06P0760
·
Abbott GmbH
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alinity
- Primary DI
- 00380740117214
- Version / Model
- 06P0760
- Catalog Number
- 06P0760
- Company Name
- Abbott GmbH
- Labeler DUNS
- 315786293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-14
- Public Version
- 15
- Public Version Date
- 2023-12-21
- Public Version Status
- Update
- Public Device Record Key
- f8db65ef-a814-4164-83be-d82a1308164f
Device Description
Alinity s HTLV I/II Reagent Kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 48524 | Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay | 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 a chemiluminescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380740117214 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius