Devices

Cepheid Xpert MRSA/SA Blood Culture

Model / Serial
Product codes GXMRSA/SA-BC-10 (lot numbers 00601, 00602, 00603, 00701, 00801, 00901, 00902, 00903, 00904, 01001, 01101, 01102, 01301, 01302) and GXMRSA/SA-BC-CE-10 (lot numbers 01001, 01101, 01301)
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA and Europe, Taiwan, and Australia.
Product Description
Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA. || Medical device, qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aures DNA directly from patient positive blood cultures. It is not intended to monitor treatment for MRSA/SA infections. Sub culturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing.
Manufacturer
Cepheid
1 Event
- Recall of Cepheid Xpert MRSA/SA Blood Culture

Manufacturer

Cepheid

Manufacturer Address
Cepheid, 904 E Caribbean Dr, Sunnyvale CA 94089-1189
Manufacturer Parent Company (2017)
Danaher Corporation
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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