Cell-Chex
Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 1 vial each…
Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 1 vial each of L1-UC, L1-CC, LV2.
1manufacturer
7catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Streck LLC, 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, Complaint-file establishment, Manufacturer |
| 510(k) | K101335 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 10 °C |
| Sizes | Total volume 2 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 212424 | Total Volume 2.0 ml | In distribution |
| 212425 | Total Volume 2.0 ml | In distribution |
| 212432 | Total Volume 2.0 ml | In distribution |
| 212429 | Total Volume 2.0 ml | In distribution |
| 212430 | Total Volume 2.0 ml | In distribution |
| 212431 | Total Volume 2.0 ml | In distribution |
| 212420 | Total Volume 2.0 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Para 12 Extend | Streck LLC | 11 |
| STaK-Chex Plus Retics | Streck LLC | 6 |
| Cell-DYN | Abbott Laboratories | 6 |
| Alinity | Abbott Medical | 2 |
| e-CHECK(XS) | Sysmex Corporation | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111211 | 2011-12-22 |
| K110718 | 2011-05-26 |
| K101335 | 2010-08-23 |
| K090137 | 2009-03-18 |
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.