FDA.reportPublic FDA data

CEPHEID

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30045302583004530258CEPHEID1N2026-01-01904 CARIBBEAN DRIVE Sunnyvale CA US 94089
30168389633016838963Cepheid1Y2026-01-01121 N Guild Ave 1175 S Guild Avenue Lodi CA US 95240
30179940493017994049CEPHEID1Y2026-01-0144509 Pacific Commons Boulevard Fremont CA US 94538

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07332940000196Xpert MRSA - Xpert MRSA kit; 10 test kit1888 838 3222techsupport@cepheid.com
07332940003388GeneXpert Dx System - XPERT, GENEXPERT DX SYSTEM18888383222techsupport@cepheid.com
07332940003449GeneXpert Dx System - XPERT, GENEXPERT DX SYSTEM(888)838-3222techsupport@cepheid.com
07332940006709GeneXpert Dx System - XPERT, GENEXPERT DX SYSTEM18888383222techsupport@cepheid.com
07332940007072Xpert® - Xpert Xpress MVP1 888 838 3222techsupport@cepheid.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
724541066786498K261362Xpert Hemorrhagic FeverQVR2026-08-07
3035761066786498K261362Xpert Hemorrhagic FeverQVR2026-08-07
724541354893967K261336Xpert Respiratory PanelQOF2026-09-25
3035761354893967K261336Xpert Respiratory PanelQOF2026-09-25
3035761007832302K251721Xpert GI PanelPCH2026-01-16
724541007832302K251721Xpert GI PanelPCH2026-01-16
3035761203900238K250996Xpert Xpress CoV-2/Flu/RSV plusQOF2025-05-01
724541203900238K250996Xpert Xpress CoV-2/Flu/RSV plusQOF2025-05-01
724542073702245K250995Xpert Xpress CoV-2/Flu/RSV plusQOF2025-05-01
3035762073702245K250995Xpert Xpress CoV-2/Flu/RSV plusQOF2025-05-01
724541739876093K250218Xpert® FII & FVNPR2025-02-21
3035761739876093K250218Xpert® FII & FVNPR2025-02-21
3035761209263950K243730Xpert C. difficile/EpiOZN2025-02-28
724541209263950K243730Xpert C. difficile/EpiOZN2025-02-28
724542054428193K243625Xpert MRSA/SA SSTINQX2024-12-18
3035762054428193K243625Xpert MRSA/SA SSTINQX2024-12-18
3035761796181217K243405Xpert vanANIJ2024-11-21
724541796181217K243405Xpert vanANIJ2024-11-21
724541557321500K243070Xpert® SA Nasal CompleteNQX2024-10-25
3035761557321500K243070Xpert® SA Nasal CompleteNQX2024-10-25
3035761777220112K242109Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX2025-01-15
724541777220112K242109Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX2025-01-15
724541373971836K242071Xpert Xpress CoV-2/Flu/RSV plusQOF2025-01-10
3035761373971836K242071Xpert Xpress CoV-2/Flu/RSV plusQOF2025-01-10
724542072994464K231481Xpert Xpress CoV-2/Flu/RSV plusQOF2023-08-17
3035762072994464K231481Xpert Xpress CoV-2/Flu/RSV plusQOF2023-08-17
3035761480489512K231381Xpert Xpress MVP; GeneXpert Xpress SystemPQA2023-10-19
724541480489512K231381Xpert Xpress MVP; GeneXpert Xpress SystemPQA2023-10-19
3035761315727256K230440Xpert® Xpress CoV-2 plusQQX2023-10-13
724541315727256K230440Xpert® Xpress CoV-2 plusQQX2023-10-13
724541208993481K223046Xpert® FII & FVNPR2023-02-15
3035761208993481K223046Xpert® FII & FVNPR2023-02-15
3035761821207743K222638Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsNJR2023-09-27
724541821207743K222638Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsNJR2023-09-27
724541937092704K221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemPQA2022-06-07
3035761937092704K221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemPQA2022-06-07
724541663454779K212213Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemPQA2022-02-09
3035761663454779K212213Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemPQA2022-02-09
724541512022596K203429Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemNJR2022-05-09
3035761512022596K203429Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemNJR2022-05-09
3035761234014364K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemNQX2019-04-25
724541234014364K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemNQX2019-04-25
724541207753024K190441Xpert 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 KitQEP2019-05-23
3035761207753024K190441Xpert 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 KitQEP2019-05-23
724541890596146K190076Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 SystemsOYX2019-09-27
3035761890596146K190076Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 SystemsOYX2019-09-27
724541211757809K181289Xpert 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 SystemOCC2018-08-15
3035761211757809K181289Xpert 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 SystemOCC2018-08-15
724541723053307K180218Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IVOCC2018-07-24
3035761723053307K180218Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IVOCC2018-07-24
724541554128494K173840Xpert CT/NGLSL2018-03-16
724541579590830K173398Xpert Xpress Strep APGX2018-04-26
3035761579590830K173398Xpert Xpress Strep APGX2018-04-26
724541355161190K173263Xpert Carba-RPOC2018-01-09
3035761355161190K173263Xpert Carba-RPOC2018-01-09
724541991410113K172126Xpert Xpress Strep APGX2017-09-25
3035761991410113K172126Xpert Xpress Strep APGX2017-09-25
724541738301248K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IVOCC2017-12-19
3035761738301248K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IVOCC2017-12-19
724541468355796K162456Xpert 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 SystemOCC2017-02-13
3035761468355796K162456Xpert 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 SystemOCC2017-02-13
724541588933749K162444Xpert MRSA NxGNQX2016-11-23
724541134766136K162331Xpert 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 SystemOCC2017-02-09
3035761134766136K162331Xpert 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 SystemOCC2017-02-09
3035761527063668K161619Xpert 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 SystemsOUY2016-08-29
724541527063668K161619Xpert 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 SystemsOUY2016-08-29
724541182033779K160901Xpert Carba-RPOC2016-06-29
3035761182033779K160901Xpert Carba-RPOC2016-06-29
724541202004332K151565Xpert® 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 KitOUY2015-10-16
3035761202004332K151565Xpert® 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 KitOUY2015-10-16
724541508461026K151226Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)OCC2015-12-03
3035762017860512K143302Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80PEU2015-02-12
724542017860512K143302Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80PEU2015-02-12
724541648680199K142501Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemPCH2014-11-26
3035761648680199K142501Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemPCH2014-11-26
724541962348036K142045XPERT FLU/RSV XC ASSAYOCC2014-11-22
724541855059439K130894XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENENQX2013-06-20
3035761855059439K130894XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENENQX2013-06-20
724541353905801K121710XPERT CT/NGLSL2012-12-27
724541690416004K121539XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)NJR2012-11-02
3035761690416004K121539XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)NJR2012-11-02
724541482396226K110203XPERT C. DIFFICLE/EPI ASSAYOMN2011-04-07
3035761482396226K110203XPERT C. DIFFICLE/EPI ASSAYOMN2011-04-07
724541068492019K100822XPERT MRSA/SA NASAL ASSAYNQX2010-06-01
3035761068492019K100822XPERT MRSA/SA NASAL ASSAYNQX2010-06-01
724541029590850K092953Xpert VanA AssayNIJ2009-12-17
3035761029590850K092953Xpert VanA AssayNIJ2009-12-17
724541011281109K091109XPERT C. DIFFICILELLH2009-07-09
3035761011281109K091109XPERT C. DIFFICILELLH2009-07-09
724541567106499K082118XPERT HEMOSIL FACTOR II & FACTOR V ASSAYNPQ2009-09-18
3035761567106499K082118XPERT HEMOSIL FACTOR II & FACTOR V ASSAYNPQ2009-09-18
724541955442947K080837XPERT MRSA/SA SSTI ASSAYNQX2008-09-24
3035761955442947K080837XPERT MRSA/SA SSTI ASSAYNQX2008-09-24
724542001082101K070462XPERT MRSANQX2007-04-17
3035762001082101K070462XPERT MRSANQX2007-04-17
724541901289748K062948SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7BNJR2006-12-08
3035761901289748K062948SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7BNJR2006-12-08
724541805655238K060540XPERT, GENEXPERT DX SYSTEMNJR2006-07-25
3035761805655238K060540XPERT, GENEXPERT DX SYSTEMNJR2006-07-25
724541348060265DEN240016Xpert HCV; GeneXpert Xpress SystemSBP2024-06-27
3035761348060265DEN240016Xpert HCV; GeneXpert Xpress SystemSBP2024-06-27
724541215801096DEN130032XPERT MTB/RIF ASSAYPEU2013-07-25
3035761215801096DEN130032XPERT MTB/RIF ASSAYPEU2013-07-25
724541456945752DEN070004XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065OAI2007-03-16
724541273472965
724541424225461
724541466590754
724541488611294
724541496081578
724541610239768
724541761012238
724541838231121
724541927853056
724541953096354
724541000186528
3035761000186528
724541059545504
3035761059545504
724541130522441
724541133634053

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NQX152024-12-18
OCC122018-08-15
QOF102026-09-25
NJR102023-09-27
PQA62023-10-19
PCH42026-01-16
NPR42025-02-21
QQX42025-01-15
NIJ42024-11-21
PGX42018-04-26
POC42018-01-09
OUY42016-08-29
PEU42015-02-12
QVR22026-08-07
OZN22025-02-28
SBP22024-06-27
OYX22019-09-27
QEP22019-05-23
LSL22018-03-16
OMN22011-04-07
NPQ22009-09-18
LLH22009-07-09
OAI12007-03-16

PMN#

44 records. Showing 41-44. Previous

GUDID#

141 records. Showing 1-40. Next