ABX Pentra DX 120
ABX Pentra DX 120 (110V), ABX Pentra DX 120 (100V)
3manufacturers in China registered for this device type
4catalogue numbers in this listing
6510(k) clearances naming this product code
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 | Horiba ABX SAS, France |
|---|---|
| FDA product code | GKZ |
| Device type | Counter, Differential Cell |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5220 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K050719 |
| Record published | 2016-09-20 |
| Record revised | 2024-05-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1280100084, 1280100085, 1280100086, 1280100088 | In distribution | |
| 1280100120, 1280100121, 1280100122, 1280100124 | In distribution | |
| 1280100078 | In distribution | |
| 1280100123, 1280100137 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QBC Diagnostics | Drucker Diagnostics, LLC | 41 |
| Cell-DYN | Abbott Laboratories | 19 |
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 17 |
| 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 |
Showing 12 of 245. All products under Counter, Differential Cell
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232946 | 2024-05-21 |
| K170353 | 2017-11-01 |
| K151133 | 2015-12-09 |
| K141161 | 2014-12-20 |
| K053308 | 2005-12-29 |
| K050719 | 2005-04-26 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|---|---|
| Horiba Instruments Incorporated | 510(k) number | 2006-03-24 | Not classified | Other | Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample. | 2012-05-23 |
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.