Devices

Synchron Phenobarbital (PHE) Reagent

Model / Serial
M810083 and earlier
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution--USA (nationwide) and the country of Canada.
Product Description
Synchron Phenobarbital (PHE) Reagent, P/N 469785, || Classification Product Code: KLT. || Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. || PHE reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 1, is intended for quantitative determination of Phenobarbital concentration in human serum or plasma.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Synchron Phenobarbital (PHE) Reagent

Manufacturer

Beckman Coulter Inc.

Manufacturer Address
Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

2 devices with a similar name

Learn more about the data here

Synchron Phenobarbital (PHE) Reagent and Synchron Systems Drug Calibrator 1

Model / Serial
Manufacturer
Beckman Coulter Inc

SYNCHRON Phenobarbital (PHE) Reagent

Model / Serial
469785 | M810083 and earlier
Product Description
IVD: Phenobarbital kit, Drug calibrator
Manufacturer
Beckman Coulter, Inc.

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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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