Alinity
ALINITY h-series CONTROL 29P
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Jilin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
Record
| Listed by | Abbott Medical, United States |
|---|---|
| FDA product code | GLQ |
| Device type | Mixture, Control, White-Cell And Red-Cell Indices |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K000945 |
| Record published | 2023-11-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 10 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04U7212 | In distribution | |
| 04U7206 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Para 12 Extend | Streck LLC | 11 |
| Cell-Chex | Streck LLC | 7 |
| STaK-Chex Plus Retics | Streck LLC | 6 |
| Cell-DYN | Abbott Laboratories | 6 |
| e-CHECK(XS) | Sysmex Corporation | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.