Cepheid
Cepheid holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2026, with 12 FDA device recalls on record.
Name variants for Cepheid
as filed with FDA- Cepheid
- Cepheid®
Top product codes for Cepheid
FDA recalls by Cepheid
10 most recent of 12- Z-0724-2026 — Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
- Z-0960-2026 — Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
- Z-0959-2026 — Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
- Z-0414-2026 — Xpert 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 qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique
- Z-2584-2024 — Cepheid, Sample Collection Device, Part: 900-0370
- Z-0215-2024 — Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
- Z-0216-2024 — Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
- Z-0592-2018 — 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.
- 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.
- Z-2548-2016 — Xpert 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-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonization
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Cepheid
- K261362 — Xpert Hemorrhagic Fever
- K261867 — Xpert Carba-R
- K253653 — Xpert Hemorrhagic Fever
- K251721 — Xpert GI Panel
- K250995 — Xpert Xpress CoV-2/Flu/RSV plus
- K250996 — Xpert Xpress CoV-2/Flu/RSV plus
- K243730 — Xpert C. difficile/Epi
- K250218 — Xpert® FII & FV
- K242109 — Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
- K242071 — Xpert Xpress CoV-2/Flu/RSV plus
- K243625 — Xpert MRSA/SA SSTI
- K243405 — Xpert vanA
- K243070 — Xpert® SA Nasal Complete
- DEN240016 — Xpert HCV; GeneXpert Xpress System
- K231381 — Xpert Xpress MVP; GeneXpert Xpress System
- K230440 — Xpert® Xpress CoV-2 plus
- K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
- K231481 — Xpert Xpress CoV-2/Flu/RSV plus
- K223046 — Xpert® FII & FV
- K221160 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
- K203429 — Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
- K212213 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
- K190076 — Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
- K190441 — 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
- K190771 — Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
- K181289 — 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
- K180218 — Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
- K173398 — Xpert Xpress Strep A
- K173840 — Xpert CT/NG
- K173263 — Xpert Carba-R
- K171552 — Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
- K172126 — Xpert Xpress Strep A
- K162456 — 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
- K162331 — 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
- K162444 — Xpert MRSA NxG
- K161619 — 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
- K160901 — Xpert Carba-R
- K152614 — Xpert Carba-R
- K151226 — Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)
- K151565 — 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
- K143302 — Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
- K142501 — 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
- K142045 — XPERT FLU/RSV XC ASSAY
- DEN130032 — XPERT MTB/RIF ASSAY
- K130894 — XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM
- K121710 — XPERT CT/NG
- K123191 — XPERT FLU
- K121539 — XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
- K120911 — XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
- K103766 — XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0
- K110203 — XPERT C. DIFFICLE/EPI ASSAY
- K101879 — XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
- K100822 — XPERT MRSA/SA NASAL ASSAY
- K092953 — Xpert VanA Assay
- K082118 — XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
- K091109 — XPERT C. DIFFICILE
- K082140 — XPERT MRSA/SA BLOOD CULTURE ASSAY
- K080837 — XPERT MRSA/SA SSTI ASSAY
- K070462 — XPERT MRSA
- DEN070004 — XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065
- K062948 — SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
- K060540 — XPERT, GENEXPERT DX SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.