Abacus 3CP Hematology Analyzer

The Abacus 3 Cap Piercer (Abacus 3CP) is a fully automated, bench top hematology cell counter, is a device used to identify one or more of the formed elements of the blood. The Diatron…

Registry build 21.09.26

The Abacus 3 Cap Piercer (Abacus 3CP) is a fully automated, bench top hematology cell counter, is a device used to identify one or more of the formed elements of the blood. The Diatron Abacus 3 CP System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters: WBC, LYM%, LYM#, MID%, MID#, GRA%,GRA#, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV in EDTA anti-coagulated venous whole blood samples.

3manufacturers in China registered for this device type
1catalogue number

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 Abacus 3CP Hematology Analyzer
Listed by Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
FDA product code GKZ
Device type Counter, Differential Cell
Device class Class 2
Regulation 21 CFR 864.5220
Record published 2016-10-06
Record revised 2024-05-16 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number
Storage Handling environment temperature 20 to 25 °C; Storage environment humidity 10 to 80 % RH; Storage environment temperature 15 to 30 °C
Packaging Box
Sizes Depth 492 mm; width 316 mm; height 360 mm

Catalogue Numbers

Catalogue numbers for Abacus 3CP Hematology Analyzer
Catalogue number Size Status
ABACUS 3CP Depth 492 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
QBC Diagnostics Drucker Diagnostics, LLC 41
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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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer