ABACUS 3CP  Hematology Analyzer A3CPC-1

GUDID 15999883586713

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.

Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Haematological cell analyser IVD, automated Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD

• Primary Device ID: 15999883586713
• NIH Device Record Key: afc58ab8-25fa-426c-b774-851a7e7ab035
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABACUS 3CP Hematology Analyzer
• Version Model Number: ABACUS 3CP
• Catalog Number: A3CPC-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: 360 Millimeter
• Height: 360 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter
• Depth: 492 Millimeter
• Width: 316 Millimeter
• Height: 360 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05999883586716 [Primary]
GS1	15999883586713 [Package]; Contains: 05999883586716; 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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