Who else makes this device?

Name: ABX Micros ES 60
Brand: ABX Micros ES 60

Hematology › Automated Hematology DevicesCounter, Differential Cell

ABX Micros ES 60

ABX MICROS ES 60 is an automated hematology analyzer for whole blood testing in clinical laboratories. It provides complete blood counts and a three part white blood cell differential,…

Registry build 21.09.26

ABX MICROS ES 60 is an automated hematology analyzer for whole blood testing in clinical laboratories. It provides complete blood counts and a three part white blood cell differential, together with hemoglobin measurement and derived red cell and platelet parameters.

Diluted blood cells pass through a small aperture between electrodes. Each cell briefly increases electrical resistance, producing a pulse whose number indicates cell count and whose size reflects cell volume. Separate chambers process red cells and platelets, and white cells and hemoglobin.

Hemoglobin and Differential

A lysing reagent releases hemoglobin for optical measurement at 550 nm. Its differing effects on white cell membranes allow lymphocytes, monocytes and granulocytes to be separated by size. The instrument is available in open or closed tube sampling versions.

3manufacturers in China registered for this device type

1catalogue number

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.

Chinese manufacturers registered for FDA product code GKZ
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

Regulatory record for ABX Micros ES 60
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	2016-05-02
Record revised	2024-05-16 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	serial number

Catalogue Numbers

Catalogue numbers for ABX Micros ES 60
Catalogue number	Size	Status
1280200072		In distribution

Same Product Code

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BD Multitest	Becton, Dickinson AND Company	6
Coulter AcT	Beckman Coulter, Inc.	6
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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

FDA 510(k) clearances naming this product code
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.