Devices

ABX Pentra Micro ALBUMIN 2 CP

Model / Serial
All lot numbers; Software Version(s): Application versions below (V5.14 & V2.12) for Pentra 400 and Versions below (V1.07) for Pentra C400
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) and to countries of: Bulgaria, Burma, Cameroon, Djibouti, France, Gabon, Germany, Italy, Lebanon, Mali, Mauritania, Poland, Portugal, Romania, Saudi Arabia, South Africa and Thailand.
Product Description
ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 || The device is intended for use in conjunction with certain materials to measure a variety of analytes.
Manufacturer
Horiba Instruments, Inc dba Horiba Medical
1 Event
- Recall of ABX Pentra Micro ALBUMIN 2 CP

Manufacturer

Horiba Instruments, Inc dba Horiba Medical

Manufacturer Address
Horiba Instruments, Inc dba Horiba Medical, 34 Bunsen, Irvine CA 92618-4210
Manufacturer Parent Company (2017)
Horiba Ltd.
Source
USFDA

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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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