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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