FDA Device Entity Profile: CEPHEID

Known Identifiers & Locations

FEI Numbers 3004530258, 3009613136, 3016838963

Owner Operator Numbers 9062742

Locations Covered Lodi, CA, US; SOLNA Stockholm, SE; Sunnyvale, CA, US

Registered Establishments (3)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3004530258	CEPHEID	Sunnyvale, CA, US	Develop Specifications But Do Not Manufacture At This Facility	View Details
3009613136	CEPHEID AB	SOLNA Stockholm, SE	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3016838963	Cepheid	Lodi, CA, US	Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0028-2018	Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individuals with signs and symptoms of meningitis. Reason: Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.	2017-09-15	Terminated	View Details

Profile Disclaimer

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