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Cepheid

62 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Xpert Hemorrhagic Fever (K261362)Cepheid2026-08-07
Xpert Carba-R (K261867)Cepheid®2026-07-02
Xpert Hemorrhagic Fever (K253653)Cepheid2026-02-20
Xpert GI Panel (K251721)Cepheid2026-01-16
Xpert Xpress CoV-2/Flu/RSV plus (K250996)Cepheid®2025-05-01
Xpert Xpress CoV-2/Flu/RSV plus (K250995)Cepheid®2025-05-01
Xpert C. difficile/Epi (K243730)Cepheid®2025-02-28
Xpert® FII & FV (K250218)Cepheid2025-02-21
Xpert® Xpress CoV-2 plus (XPRS-COV2-10) (K242109)Cepheid®2025-01-15
Xpert Xpress CoV-2/Flu/RSV plus (K242071)Cepheid2025-01-10
Xpert MRSA/SA SSTI (K243625)Cepheid®2024-12-18
Xpert vanA (K243405)Cepheid®2024-11-21
Xpert® SA Nasal Complete (K243070)Cepheid®2024-10-25
Xpert HCV; GeneXpert Xpress System (DEN240016)Cepheid2024-06-27
Xpert Xpress MVP; GeneXpert Xpress System (K231381)Cepheid2023-10-19
Xpert® Xpress CoV-2 plus (K230440)Cepheid®2023-10-13
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems (K222638)Cepheid2023-09-27
Xpert Xpress CoV-2/Flu/RSV plus (K231481)Cepheid®2023-08-17
Xpert® FII & FV (K223046)Cepheid®2023-02-15
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (K221160)Cepheid2022-06-07
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (K203429)Cepheid2022-05-09
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (K212213)Cepheid2022-02-09
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems (K190076)Cepheid2019-09-27
Xpert 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 Kit (K190441)Cepheid2019-05-23
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (K190771)Cepheid2019-04-25
Xpert 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 System (K181289)Cepheid2018-08-15
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV (K180218)Cepheid2018-07-24
Xpert Xpress Strep A (K173398)Cepheid2018-04-26
Xpert CT/NG (K173840)Cepheid2018-03-16
Xpert Carba-R (K173263)Cepheid2018-01-09
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV (K171552)Cepheid2017-12-19
Xpert Xpress Strep A (K172126)Cepheid2017-09-25
Xpert 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 System (K162456)Cepheid2017-02-13
Xpert 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 System (K162331)Cepheid2017-02-09
Xpert MRSA NxG (K162444)Cepheid2016-11-23
Xpert 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 Systems (K161619)Cepheid2016-08-29
Xpert Carba-R (K160901)Cepheid2016-06-29
Xpert Carba-R (K152614)Cepheid2016-03-07
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) (K151226)Cepheid2015-12-03
Xpert® 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 Kit (K151565)Cepheid2015-10-16
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 (K143302)Cepheid2015-02-12
Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (K142501)Cepheid2014-11-26
XPERT FLU/RSV XC ASSAY (K142045)Cepheid2014-11-22
XPERT MTB/RIF ASSAY (DEN130032)Cepheid2013-07-25
XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE (K130894)Cepheid2013-06-20
XPERT CT/NG (K121710)Cepheid2012-12-27
XPERT FLU (K123191)Cepheid2012-12-21
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) (K121539)Cepheid2012-11-02
XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) (K120911)Cepheid2012-05-18
XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 (K103766)Cepheid2011-04-21
XPERT C. DIFFICLE/EPI ASSAY (K110203)Cepheid2011-04-07
XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 (K101879)Cepheid2010-07-28
XPERT MRSA/SA NASAL ASSAY (K100822)Cepheid2010-06-01
Xpert VanA Assay (K092953)Cepheid2009-12-17
XPERT HEMOSIL FACTOR II & FACTOR V ASSAY (K082118)Cepheid2009-09-18
XPERT C. DIFFICILE (K091109)Cepheid2009-07-09
XPERT MRSA/SA BLOOD CULTURE ASSAY (K082140)Cepheid2008-09-29
XPERT MRSA/SA SSTI ASSAY (K080837)Cepheid2008-09-24
XPERT MRSA (K070462)Cepheid2007-04-17
XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065 (DEN070004)Cepheid2007-03-16
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B (K062948)Cepheid2006-12-08
XPERT, GENEXPERT DX SYSTEM (K060540)Cepheid2006-07-25

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Every clearance here is in the API, with alerts when new ones post.