Research and Diagnostic Systems
R&D LeukoReduced Combo Kit: 4 x 3mL (1 ea L & H of PLT/RBC)
3manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Onechipdx Biotech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Specification developer | 2 |
Record
| Listed by | Research AND Diagnostic Systems, Inc. |
|---|---|
| FDA product code | GKZ |
| Device type | Counter, Differential Cell |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5220 |
| Record published | 2016-07-29 |
| Record revised | 2018-03-29 (version 2) |
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 8 °C; Handling environment temperature 2 to 8 °C |
| Sizes | Total volume 1.5 to 20 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FC238 | Total Volume 3 ml | In distribution | |
| FC202 | Total Volume 5 ml | 2 | In distribution |
| FC402 | Total Volume 10 ml | 4 | In distribution |
| LRP001 | Total Volume 6 ml | In distribution | |
| FC504 | Total Volume 20 ml | 5 | In distribution |
| FC204 | Total Volume 8 ml | 2 | In distribution |
| LRC001 | Total Volume 12 ml | In distribution | |
| FC236L | Total Volume 3 ml | 2 | In distribution |
| FC237 | Total Volume 5 ml | 2 | In distribution |
| FC404 | Total Volume 16 ml | 4 | In distribution |
| FC236H | Total Volume 3 ml | 2 | In distribution |
| FC235 | Total Volume 2.5 ml | In distribution | |
| LRR001 | Total Volume 6 ml | In distribution | |
| FC502 | Total Volume 12.5 ml | 5 | In distribution |
| FC234H | Total Volume 1.5 ml | In distribution | |
| FC302 | Total Volume 7.5 ml | 3 | In distribution |
| FC234L | Total Volume 1.5 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QBC Diagnostics | Drucker Diagnostics, LLC | 41 |
| Cell-DYN | Abbott Laboratories | 19 |
| Simultest | Becton, Dickinson AND Company | 10 |
| BD FACSCanto™ | Becton, Dickinson AND Company | 10 |
| FACSCanto | Becton, Dickinson AND Company | 7 |
| BD Multitest | Becton, Dickinson AND Company | 6 |
| Coulter AcT | Beckman Coulter, Inc. | 6 |
| BD™ Multi-Check | Becton, Dickinson AND Company | 6 |
| BD Tritest | Becton, Dickinson AND Company | 6 |
| Coulter LH | Beckman Coulter, Inc. | 5 |
| HemoScreen | Pixcell Medical Inc. | 5 |
| Calibrite | Becton, Dickinson AND Company | 4 |
Showing 12 of 245. All products under Counter, Differential Cell
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.