Devices

BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.

Model / Serial
All serial numbers pre-programmed with HCV singlet and HCV duplicate parameters by Roche for use with the Roche HCV test version 2.0.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and Canada.
Product Description
BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.
Manufacturer
Roche Diagnostics Corp.
1 Event
- Recall of BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.

Manufacturer

Roche Diagnostics Corp.

Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
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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