Skip to the page
Get started – free

Data / Medical devices / United States / Cepheid

Cepheid: FDA-registered device maker in Sunnyvale, CA, United States, 52 510(k) clearances

Cepheid is registered with the FDA (registration 3004530258) in Sunnyvale, CA, United States. It lists 38 device types. The FDA files 52 510(k) clearances under its listings, the newest dated September 25, 2026. 15 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Cepheid
FDA registration number
3004530258
Address
904 Caribbean Drive, Sunnyvale, CA, United States, 94089
Owner or operator
CEPHEID (9062742)
Roles
Manufacturer, Manufacturer for export, Specification developer
First device listed
April 13, 2004
Registered through
2026
Brand names listed
G3 module, GeneXpert DX systems, GeneXpert Edge System (For Export Only), GeneXpert Edge X, GeneXpert Infinity Systems, GeneXpert Infinity-48s system, GeneXpert Infinity-80 System, GeneXpert Xpress System and more

Devices it lists

DeviceProduct codeClassRoleSource
Assay, Direct, Nucleic Acid Amplification, Influenza VirusNIA1Manufacturer for exportaccessdata.fda.gov
Assay, Enterovirus Nucleic AcidOAI2Manufactureraccessdata.fda.gov
Bcr/Abl1 Monitoring TestOYX2Manufacturer, Manufacturer for exportaccessdata.fda.gov
C. Difficile Nucleic Acid Amplification Test AssayOMN1Manufactureraccessdata.fda.gov
C. Difficile Toxin Gene Amplification AssayOZN2Manufacturer, Specification developeraccessdata.fda.gov
Clinical Sample ConcentratorJJH1Manufacturer for exportaccessdata.fda.gov
Culture Media, Non-Propagating TransportJSM1Manufacturer, Specification developeraccessdata.fda.gov
Dna Probe, Nucleic Acid Amplification, ChlamydiaMKZ1Manufacturer, Manufacturer for exportaccessdata.fda.gov
Dna-Based Test For Minimal Residual Disease For Hematologic MalignanciesQDC2Manufacturer for exportaccessdata.fda.gov
Dna-Reagents, NeisseriaLSL2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemPCH2Manufacturer, Specification developeraccessdata.fda.gov
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification SystemPGX2Manufacturer, Manufacturer for export, Specification developeraccessdata.fda.gov
Instrumentation For Clinical Multiplex Test SystemsNSU2Manufactureraccessdata.fda.gov
Microbial Nucleic Acid Storage And Stabilization DeviceQBD2Manufactureraccessdata.fda.gov
Multi-Analyte Controls UnassayedOHQ1Manufacturer, Manufacturer for exportaccessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsQOF2Manufacturer, Specification developeraccessdata.fda.gov
Multiplex Nucleic Acid Detection System For Biothreat AgentsQVR2Specification developeraccessdata.fda.gov
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen TestNJR1Manufacturer, Manufacturer for export, Specification developeraccessdata.fda.gov
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted InfectionsQEP2Manufactureraccessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic AcidQJRNManufacturer, Manufacturer for exportaccessdata.fda.gov
Reagents, Clostridium Difficile ToxinLLH1Manufactureraccessdata.fda.gov
Reagents, Monkeypox Virus Nucleic Acid.QTPNManufactureraccessdata.fda.gov
Real Time Nucleic Acid Amplification SystemOOI2Manufacturer, Manufacturer for export, Specification developeraccessdata.fda.gov
Respiratory Specimen Nucleic Acid Sars-Cov-2 TestQQX2Manufacturer, Specification developeraccessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay SystemOCC2Manufacturer, Specification developeraccessdata.fda.gov
Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid TestSBP2Specification developeraccessdata.fda.gov
Somatic Gene Mutation Detection SystemOWD3Manufacturer for exportaccessdata.fda.gov
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct SpecimenPOC2Manufacturer, Manufacturer for exportaccessdata.fda.gov
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, ColonyPMY2Manufactureraccessdata.fda.gov
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct SpecimenNQX2Manufacturer, Manufacturer for export, Specification developeraccessdata.fda.gov
System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct SpecimenPEU2Manufacturer, Manufacturer for exportaccessdata.fda.gov
System, Test, Genotypic Detection, Resistant Markers, Enterococcus SpeciesNIJ2Manufactureraccessdata.fda.gov
System, Test, Tumor Marker, For Detection Of Bladder CancerNAH3Manufacturer for exportaccessdata.fda.gov
System, Test, Tumor Marker, Monitoring, BladderMMW2Manufacturer for exportaccessdata.fda.gov
Test, Factor Ii G20210a Mutations, Genomic Dna PcrNPR2Manufacturer, Manufacturer for export, Specification developeraccessdata.fda.gov
Test, Factor V Leiden Mutations, Genomic Dna PcrNPQ2Manufacturer, Specification developeraccessdata.fda.gov
Trichomonas Vaginalis Nucleic Acid Amplification Test SystemOUY2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection SystemPQA2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 25, 2026K261336Xpert Respiratory PanelQOFSubstantially EquivalentCepheidaccessdata.fda.gov
August 7, 2026K261362Xpert Hemorrhagic FeverQVRSubstantially EquivalentCepheidaccessdata.fda.gov
January 16, 2026K251721Xpert GI PanelPCHSubstantially EquivalentCepheidaccessdata.fda.gov
May 1, 2025K250996Xpert Xpress CoV-2/Flu/RSV plusQOFSubstantially EquivalentCepheid®accessdata.fda.gov
May 1, 2025K250995Xpert Xpress CoV-2/Flu/RSV plusQOFSubstantially EquivalentCepheid®accessdata.fda.gov
February 28, 2025K243730Xpert C. difficile/EpiOZNSubstantially EquivalentCepheid®accessdata.fda.gov
February 21, 2025K250218Xpert® FII & FVNPRSubstantially EquivalentCepheidaccessdata.fda.gov
January 15, 2025K242109Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQXSubstantially EquivalentCepheid®accessdata.fda.gov
January 10, 2025K242071Xpert Xpress CoV-2/Flu/RSV plusQOFSubstantially EquivalentCepheidaccessdata.fda.gov
December 18, 2024K243625Xpert MRSA/SA SSTINQXSubstantially EquivalentCepheid®accessdata.fda.gov
November 21, 2024K243405Xpert vanANIJSubstantially EquivalentCepheid®accessdata.fda.gov
October 25, 2024K243070Xpert® SA Nasal CompleteNQXSubstantially EquivalentCepheid®accessdata.fda.gov
June 27, 2024DEN240016Xpert HCV; GeneXpert Xpress SystemSBPUnknownCepheidaccessdata.fda.gov
October 19, 2023K231381Xpert Xpress MVP; GeneXpert Xpress SystemPQASubstantially EquivalentCepheidaccessdata.fda.gov
October 13, 2023K230440Xpert® Xpress CoV-2 plusQQXSubstantially EquivalentCepheid®accessdata.fda.gov
September 27, 2023K222638Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsNJRSubstantially EquivalentCepheidaccessdata.fda.gov
August 17, 2023K231481Xpert Xpress CoV-2/Flu/RSV plusQOFSubstantially EquivalentCepheid®accessdata.fda.gov
February 15, 2023K223046Xpert® FII & FVNPRSubstantially EquivalentCepheid®accessdata.fda.gov
June 7, 2022K221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemPQASubstantially EquivalentCepheidaccessdata.fda.gov
May 9, 2022K203429Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemNJRSubstantially EquivalentCepheidaccessdata.fda.gov
February 9, 2022K212213Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemPQASubstantially EquivalentCepheidaccessdata.fda.gov
September 27, 2019K190076Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 SystemsOYXSubstantially EquivalentCepheidaccessdata.fda.gov
May 23, 2019K190441Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection KitQEPSubstantially EquivalentCepheidaccessdata.fda.gov
April 25, 2019K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemNQXSubstantially EquivalentCepheidaccessdata.fda.gov
August 15, 2018K181289Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 SystemOCCSubstantially EquivalentCepheidaccessdata.fda.gov
July 24, 2018K180218Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IVOCCSubstantially EquivalentCepheidaccessdata.fda.gov
April 26, 2018K173398Xpert Xpress Strep APGXSubstantially EquivalentCepheidaccessdata.fda.gov
January 9, 2018K173263Xpert Carba-RPOCSubstantially EquivalentCepheidaccessdata.fda.gov
December 19, 2017K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IVOCCSubstantially EquivalentCepheidaccessdata.fda.gov
September 25, 2017K172126Xpert Xpress Strep APGXSubstantially EquivalentCepheidaccessdata.fda.gov
February 13, 2017K162456Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemOCCSubstantially EquivalentCepheidaccessdata.fda.gov
February 9, 2017K162331Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemOCCSubstantially EquivalentCepheidaccessdata.fda.gov
November 23, 2016K162444Xpert MRSA NxGNQXSubstantially EquivalentCepheidaccessdata.fda.gov
August 29, 2016K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 SystemsOUYSubstantially EquivalentCepheidaccessdata.fda.gov
June 29, 2016K160901Xpert Carba-RPOCSubstantially EquivalentCepheidaccessdata.fda.gov
October 16, 2015K151565Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection KitOUYSubstantially EquivalentCepheidaccessdata.fda.gov
February 12, 2015K143302Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80PEUSubstantially EquivalentCepheidaccessdata.fda.gov
November 26, 2014K142501Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemPCHSubstantially EquivalentCepheidaccessdata.fda.gov
November 22, 2014K142045XPERT FLU/RSV XC ASSAYOCCSubstantially EquivalentCepheidaccessdata.fda.gov
July 25, 2013DEN130032XPERT MTB/RIF ASSAYPEUUnknownCepheidaccessdata.fda.gov
June 20, 2013K130894XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENENQXSubstantially EquivalentCepheidaccessdata.fda.gov
November 2, 2012K121539XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)NJRSubstantially EquivalentCepheidaccessdata.fda.gov
April 7, 2011K110203XPERT C. DIFFICLE/EPI ASSAYOMNSubstantially EquivalentCepheidaccessdata.fda.gov
June 1, 2010K100822XPERT MRSA/SA NASAL ASSAYNQXSubstantially EquivalentCepheidaccessdata.fda.gov
December 17, 2009K092953Xpert VanA AssayNIJSubstantially EquivalentCepheidaccessdata.fda.gov
September 18, 2009K082118XPERT HEMOSIL FACTOR II & FACTOR V ASSAYNPQSubstantially EquivalentCepheidaccessdata.fda.gov
July 9, 2009K091109XPERT C. DIFFICILELLHSubstantially EquivalentCepheidaccessdata.fda.gov
September 24, 2008K080837XPERT MRSA/SA SSTI ASSAYNQXSubstantially EquivalentCepheidaccessdata.fda.gov
April 17, 2007K070462XPERT MRSANQXSubstantially EquivalentCepheidaccessdata.fda.gov
March 16, 2007DEN070004XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065OAIUnknownCepheidaccessdata.fda.gov
December 8, 2006K062948SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7BNJRSubstantially EquivalentCepheidaccessdata.fda.gov
July 25, 2006K060540XPERT, GENEXPERT DX SYSTEMNJRSubstantially EquivalentCepheidaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
November 5, 202597911Class IIOngoingXpert MTB/RIF. Model Number: GXMTB/RIF-US-10.Product testing did not meet expected stability criteria.accessdata.fda.gov
October 30, 202598004Class IIOngoingBrand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.accessdata.fda.gov
August 6, 202597497Class IIOngoingXpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitaAs a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.accessdata.fda.gov
June 20, 202494932Class IIOngoingCepheid, Sample Collection Device, Part:Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results.accessdata.fda.gov
April 24, 202393125Class IIOngoingXpert Xpress Strep A, XPRSTREPA-10, P/N: IVD, Rx Onlypipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.accessdata.fda.gov
October 9, 201778910Class IITerminatedXpert 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.Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its intended use specimen types. Investigation of the issue also revealed an occasional probability of false negative results which remains consistent with package insert claims.accessdata.fda.gov
September 15, 201778177Class IITerminatedXpert 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) RCustomers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.accessdata.fda.gov
July 18, 201674803Class IITerminatedXpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-ReInternal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.accessdata.fda.gov
July 27, 201571841Class IIITerminatedXpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport paFirm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.accessdata.fda.gov
November 17, 201160481Not yet classifiedTerminatedCepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (blood culture) product.accessdata.fda.gov
April 1, 201158568Not yet classifiedTerminatedXpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXpert Infinity 48A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are introduced in rapid succession.accessdata.fda.gov
April 5, 201055670Not yet classifiedTerminatedCepheid 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 aurThe firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients.accessdata.fda.gov
February 19, 201055079Not yet classifiedTerminatedCepheid 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 differentiaFirm has had an increasing number of customer complaints regarding higher than expected Indeterminate Test Results due to "Invalid" test reports from our system when they have been conducting their own internal validation studies using banked frozen repository specimens.accessdata.fda.gov
September 5, 200745494Not yet classifiedTerminatedCepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089Labeling Error: Some cartridges may be mislabeled as "Xpert EV" instead of "Xpert GBS". (The information embedded in the barcode label on the cartridge is correct for Xpert GBS and brings up the GBS assay definition file)accessdata.fda.gov
July 22, 200532756Not yet classifiedTerminatedSmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR ThermocyclerA problem in the software has the potential to be associated with the incorrect reporting of sample results.accessdata.fda.gov

Compare with other makers

Updated September 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.