Abacus 5 Hematology Analyzer A5US-1

GUDID 05999883586228

Abacus 5 is an automated differential cell counter device used to identify one or more of the formed elements of the blood. The Diatron Abacus 5 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters in K3EDTA anti-coagulated venous whole blood samples: WBC, LYM%, LYM#, MON%, MON#, NEU%, NEU#, EOS%, EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV,MCH, MCHC, RDWcv, RDWsd, PCT, PDWcv, PDWsd, PLT, MPV, PLCC, and PLCR.

Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Haematological cell analyser IVD, automated

Primary Device ID	05999883586228
NIH Device Record Key	d9b7d64a-5fc4-4ef7-a085-3456746ab714
Commercial Distribution Status	In Commercial Distribution
Brand Name	Abacus 5 Hematology Analyzer
Version Model Number	Abacus 5
Catalog Number	A5US-1
Company DUNS	427395277
Company Name	Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Height	520 Millimeter
Height	520 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter
Depth	493 Millimeter
Width	410 Millimeter
Height	520 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05999883586228 [Primary]
GS1	15999883586225 [Package] Package: Box [1 Units] In Commercial Distribution

FDA Product Code

GKZ	Counter, Differential Cell

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-12-23
Device Publish Date	2016-10-06

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