Devices

COBAS INTEGRA Cyclosporine Assay

Model / Serial
Lot number: 70002500
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution -- including, IN, NJ, NY, TX, CA, PA, OH, and FL.
Product Description
Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and Distributed by: Roche Diagnostics Corporation, Indianapolis, IN. || For the quantitative determination of Cyclosporine in whole blood, using automated clinical analyzers as an aid in management of therapy in kidney, liver, and heart transplants
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
- Recall of COBAS INTEGRA Cyclosporine Assay

Manufacturer

Roche Diagnostics Operations, Inc.

Manufacturer Address
Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
Manufacturer Parent Company (2017)
Roche Holding AG
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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