FDA UDI
In Commercial Distribution
🇺🇸 United States
Alinity
DI: 00380740215712
·
Model: 03R6584
·
ABBOTT LABORATORIES
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Alinity
- Primary DI
- 00380740215712
- Version / Model
- 03R6584
- Catalog Number
- 03R6584
- Company Name
- ABBOTT LABORATORIES
- Labeler DUNS
- 117245596
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-08
- Public Version
- 1
- Public Version Date
- 2025-10-16
- Public Version Status
- New
- Public Device Record Key
- ad134cde-1a91-468b-9741-013100d8a23e
Device Description
Alinity i Processing Module, refurbished
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DHA | SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN | Clinical Chemistry | 862.1155 | 2 |
| CEM | ELECTRODE, ION SPECIFIC, POTASSIUM | Clinical Chemistry | 862.1600 | 2 |
| JJE | Analyzer, chemistry (photometric, discrete), for clinical use | Clinical Chemistry | 862.2160 | 1 |
| JGS | ELECTRODE, ION SPECIFIC, SODIUM | Clinical Chemistry | 862.1665 | 2 |
| CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE | Clinical Chemistry | 862.1170 | 2 |
| CFR | HEXOKINASE, GLUCOSE | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56701 | Chemiluminescent immunoassay analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., protein, drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380740215712 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]