International Medical Devices Database

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

12 devices in the database

Xpert GBS

Model / Serial
Lot Number : 1402
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution
Product Description
Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089

Xpert CT/NG

Model / Serial
Lot numbers: 25718, 25719, 25725, and 25727.
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Puerto Rico, and Haiti.
Product Description
Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. || Is a qualitative in vitro real-time PCR test.

Xpert EV Assay, Catalog GXEV100N10.

Model / Serial
batch 1000045409 (lot 06802)
Distribution
USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay
Product Description
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.

Device Recall Cepheid Xpert Flu A Panel (GXFLUPANELCE10)

Model / Serial
Lot Number: 00501 (Expires 2010 08 08)
Product Classification
Immunology and Microbiology Devices
Device Class
Not Classified
Implanted device?
No
Distribution
Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.
Product Description
Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA. || Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.

Device Recall Cepheid Xpert Flu A Panel (GXFLUPANEL10)

Model / Serial
Lot Numbers: 00401, 00502, 00701, 00702 (Expires 2010 07 11 for lot 00401 and 2010 09 05 for the rest).
Product Classification
Immunology and Microbiology Devices
Device Class
Not Classified
Implanted device?
No
Distribution
Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.
Product Description
Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA. || Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.

7 more

37 manufacturers with a similar name

Learn more about the data here

CEPHEID

Manufacturer Parent Company (2017)
Danaher Corporation
Source
NIDFSINVIMA

CEPHEID || Importer: ROCHEM BIOCARE COLOMBIA S.A

Manufacturer Parent Company (2017)
Danaher Corporation
Source
NIDFSINVIMA

CEPHEID || Importer: ROCHEM BIOCARE COLOMBIA S.A.S.

Manufacturer Parent Company (2017)
Danaher Corporation
Source
NIDFSINVIMA

CEPHEID || Imported by: ROCHEM BIOCARE COLOMBIA.

Manufacturer Parent Company (2017)
Danaher Corporation
Source
NIDFSINVIMA

CEPHEID AB || Importer: ROCHEM BIOCARE COLOMBIA S.A.S.

Manufacturer Parent Company (2017)
Danaher Corporation
Source
NIDFSINVIMA

32 more

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

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.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)