International Medical Devices Database

Manufacturer Address
ABX Diagnostics Inc, 34 Bunsen, Irvine CA 92618-4210
Source
USFDA
5 Events

5 devices in the database

Pentra 80XL

Model / Serial
Part Numbers: Pentra 80XL P80XL000NUA10
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
Automated Differential Cell Counter

Pentra 80

Model / Serial
Part Numbers: Pentra 80 P8000000NUA10
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
Automated Differential Cell Counter

Pentra 80 and Pentra 80XL Hematology Analyzers

Model / Serial
All Serial numbers.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
Pentra 80 and Pentra 80XL Hematology Analyzers

Device Recall ABX Pentra 120,120R,120DX

Model / Serial
All serial numbers, all software versions.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
ABX Pentra 120,120R,120DX, automated hematology analyzer

PENTRA 120 and PENTRA 120 Retic Hematology Analyzer

Model / Serial
Any instrument which is not equipped with v4.55 or above will be upgraded.
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide.
Product Description
PENTRA 120 and PENTRA 120 Retic Hematology Analyzer

One manufacturer with a similar name

Learn more about the data here

ABX Diagnostics Inc

Manufacturer Address
ABX Diagnostics Inc, 34 Bunsen Drive, Irvine CA 92618
Source
USFDA

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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