FDA UDI
In Commercial Distribution
🇺🇸 United States
Alinity
DI: 00380740156831
·
Model: 01R5950
·
ABBOTT LABORATORIES
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Alinity
- Primary DI
- 00380740156831
- Version / Model
- 01R5950
- Catalog Number
- 01R5950
- Company Name
- ABBOTT LABORATORIES
- Labeler DUNS
- 117245596
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2018-10-03
- Public Version
- 6
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- bad8a0d0-4c96-474d-836a-1ee181979ea9
Device Description
Alinity Diagnostics Kit
Device Characteristics
- Single Use
- No
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | Clinical Chemistry | 862.2160 | 1 |
| MZA | Test, equipment, automated bloodborne pathogen | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56676 | Multiple clinical chemistry analyser IVD, laboratory | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380740156831 | GS1 | ||||
| Unit of Use | 00380740167752 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius