Cepheid - FDA 510(k) Cleared Devices

Cleared Dec 19, 2017

Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal...

K171552 · OCC

Microbiology · 207d

Cleared Sep 25, 2017

Xpert Xpress Strep A

K172126 · PGX

Microbiology · 73d

Cleared Feb 13, 2017

Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx...

K162456 · OCC

Microbiology · 164d

Cleared Feb 09, 2017

Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert...

K162331 · OCC

Microbiology · 174d

Cleared Nov 23, 2016

Xpert MRSA NxG

K162444 · NQX

Microbiology · 84d

Cleared Aug 29, 2016

Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I,...

K161619 · OUY

Microbiology · 77d

Cleared Jun 29, 2016

Xpert Carba-R

K160901 · POC

Microbiology · 89d

Cleared Mar 07, 2016

Xpert Carba-R

K152614 · PMY

Microbiology · 175d

Cleared Dec 03, 2015

Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert...

K151226 · OCC

Microbiology · 210d

Cleared Oct 16, 2015

Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx,...

K151565 · OUY

Microbiology · 128d

Cleared Feb 12, 2015

Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert...

K143302 · PEU

Microbiology · 87d

Cleared Nov 26, 2014

Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert...

K142501 · PCH

Microbiology · 82d

Cleared Nov 22, 2014

XPERT FLU/RSV XC ASSAY

K142045 · OCC

Microbiology · 117d

Not Cleared Jul 25, 2013

XPERT MTB/RIF ASSAY

DEN130032 · PEU

Microbiology · 44d

Cleared Jun 20, 2013

XPERT MRSA/SA BLOOD CULTURE ASSAY

K130894 · NQX

Microbiology · 80d

Cleared Dec 27, 2012

XPERT CT/NG

K121710 · LSL

Microbiology · 199d

Cleared Dec 21, 2012

XPERT FLU

K123191 · OCC

Microbiology · 71d

Cleared Nov 02, 2012

XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI)...

K121539 · NJR

Microbiology · 162d

Cleared May 18, 2012

XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)

K120911 · OQW

Microbiology · 53d

Cleared Apr 21, 2011

XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM...

K103766 · OQW

Microbiology · 119d

Cleared Apr 07, 2011

XPERT C. DIFFICLE/EPI ASSAY

K110203 · OMN

Microbiology · 73d

Cleared Jul 28, 2010

XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10

K101879 · NQX

Microbiology · 22d

Cleared Jun 01, 2010

XPERT MRSA/SA NASAL ASSAY

K100822 · NQX

Microbiology · 70d

Cleared Dec 17, 2009

Xpert VanA Assay

K092953 · NIJ

Microbiology · 84d

Cleared Jul 09, 2009

XPERT C. DIFFICILE

K091109 · LLH

Microbiology · 84d