Cell-DYN
CELL-DYN 29 PLUS CONTROL (with Retic)
1manufacturer
6catalogue 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 Laboratories, 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 | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K000945 |
| Record published | 2016-06-06 |
| Record revised | 2023-08-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 10 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08H58-01 | In distribution | |
| 09H72-01 | In distribution | |
| 08H58-02 | In distribution | |
| 09H69-01 | In distribution | |
| 09H72-02 | In distribution | |
| 09H69-02 | 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 |
| Alinity | Abbott Medical | 2 |
| 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.