DEVICE: ABACUS 3CP  Hematology Analyzer (05999883586716)

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Device Identifier (DI) Information

ABACUS 3CP  Hematology Analyzer
ABACUS 3CP 
A3CPC-1
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
05999883586716
GS1
1
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Haematological cell analyser IVD, automated A mains electricity (AC-powered) laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. The device operates with minimal technician involvement and complete automation of all procedural steps.
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FDA Product Code

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Product Code Product Code Name
GKZ Counter, Differential Cell
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Temperature: between 20 and 25 Degrees Celsius
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Depth: 492 Millimeter
Width: 316 Millimeter
Height: 360 Millimeter
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Device Status

In Commercial Distribution
October 06, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
15999883586716 1 05999883586716 In Commercial Distribution box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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+1207-450-4228
John.Roche@diatron.com
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