FDA 510(k) Applications Submitted by CEPHEID
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120911 |
03/26/2012 |
XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) |
CEPHEID |
| K151226 |
05/07/2015 |
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) |
CEPHEID |
| K121539 |
05/24/2012 |
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) |
CEPHEID |
| DEN130032 |
06/11/2013 |
XPERT MTB/RIF ASSAY |
CEPHEID |
| K143302 |
11/17/2014 |
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 |
CEPHEID |
| K103766 |
12/23/2010 |
XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 |
CEPHEID |
| K151565 |
06/10/2015 |
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 |
CEPHEID |
| K142501 |
09/05/2014 |
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 |
CEPHEID |
| K130894 |
04/01/2013 |
XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE |
CEPHEID |
| K080837 |
03/25/2008 |
XPERT MRSA/SA SSTI ASSAY |
CEPHEID |
| K110203 |
01/24/2011 |
XPERT C. DIFFICLE/EPI ASSAY |
CEPHEID |
| K070462 |
02/16/2007 |
XPERT MRSA |
CEPHEID |
| K060540 |
03/01/2006 |
XPERT, GENEXPERT DX SYSTEM |
CEPHEID |
| K100822 |
03/23/2010 |
XPERT MRSA/SA NASAL ASSAY |
CEPHEID |
| K091109 |
04/16/2009 |
XPERT C. DIFFICILE |
CEPHEID |
| K121710 |
06/11/2012 |
XPERT CT/NG |
CEPHEID |
| K082118 |
07/28/2008 |
XPERT HEMOSIL FACTOR II & FACTOR V ASSAY |
CEPHEID |
| K082140 |
07/30/2008 |
XPERT MRSA/SA BLOOD CULTURE ASSAY |
CEPHEID |
| K092953 |
09/24/2009 |
XPERT VANA ASSAY |
CEPHEID |
| K062948 |
09/28/2006 |
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B |
CEPHEID |
| K123191 |
10/11/2012 |
XPERT FLU |
CEPHEID |
| DEN070004 |
03/12/2007 |
XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065 |
CEPHEID |
| K101879 |
07/06/2010 |
XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 |
CEPHEID |
| K142045 |
07/28/2014 |
XPERT FLU/RSV XC ASSAY |
CEPHEID |
| K160901 |
04/01/2016 |
Xpert Carba-R |
CEPHEID |
| K161619 |
06/13/2016 |
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 |
Cepheid |
| K162331 |
08/19/2016 |
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 |
CEPHEID |
| K162444 |
08/31/2016 |
Xpert MRSA NxG |
CEPHEID |
| K162456 |
09/02/2016 |
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 |
CEPHEID |
| K152614 |
09/14/2015 |
Xpert Carba-R |
CEPHEID |
| K221160 |
04/21/2022 |
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System |
Cepheid |
| K212213 |
07/15/2021 |
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System |
Cepheid |
| K222638 |
09/01/2022 |
Xpert« Xpress GBS, GeneXpert« Dx System, GeneXpert« Infinity Systems |
Cepheid |
| K190076 |
01/16/2019 |
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems |
Cepheid |
| K180218 |
01/25/2018 |
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV |
Cepheid |
| K190441 |
02/25/2019 |
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 |
Cepheid |
| K190771 |
03/26/2019 |
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
Cepheid |
| K181289 |
05/16/2018 |
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 |
Cepheid |
| K171552 |
05/26/2017 |
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV |
Cepheid |
| K172126 |
07/14/2017 |
Xpert Xpress Strep A |
Cepheid |
| K173263 |
10/11/2017 |
Xpert Carba-R |
Cepheid |
| K173398 |
10/31/2017 |
Xpert Xpress Strep A |
Cepheid |
| K203429 |
11/20/2020 |
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System |
Cepheid |
| K173840 |
12/18/2017 |
Xpert CT/NG |
Cepheid |
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