ABX Micros ES60 CT
The ABX MICROS ES60 CT is an automated hematology analyzer for whole blood testing in clinical laboratories. It produces complete blood counts and a leukocyte differential using the…
The ABX MICROS ES60 CT is an automated hematology analyzer for whole blood testing in clinical laboratories. It produces complete blood counts and a leukocyte differential using the analyzer and its analytical reagents. The closed-tube version samples a blood collection tube through its cap.
Cells in diluted blood pass through an aperture between electrodes, changing electrical resistance. The analyzer counts these pulses and uses their size to assess cell volume. Red cells and platelets are measured in one chamber; white cells and hemoglobin are processed in another.
Listed Item
ABX Micros ES60 (C.T.B.)
Hemoglobin and Differential
Hemoglobin released by lysing reagent is measured optically. The analyzer differentiates white cells into lymphocyte, monocyte and granulocyte groups based on their measured size after reagent treatment.
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) | K141161 |
| Record published | 2016-08-23 |
| 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 |
|---|---|---|
| 1280070004 | In distribution | |
| 1280070001, 1280070005, 1280070006 | 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 |
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.