FDA UDI
In Commercial Distribution
🇺🇸 United States
Alinity
DI: 00380740163235
·
Model: 06P0103
·
Abbott GmbH
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alinity
- Primary DI
- 00380740163235
- Version / Model
- 06P0103
- Catalog Number
- 06P0103
- Company Name
- Abbott GmbH
- Labeler DUNS
- 315786293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-30
- Public Version
- 19
- Public Version Date
- 2023-12-21
- Public Version Status
- Update
- Public Device Record Key
- 7c8a2871-1b13-412d-ab03-8bb507bc169d
Device Description
Alinity s HIV Ag/Ab Combo Calibrator 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 |
|---|---|---|---|---|
| 48448 | HIV1/HIV2 antigen/antibody IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of antigens from and antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380740163235 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius