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

• 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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