Cepheid - FDA 510(k) Cleared Devices

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 Sep 18, 2009

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

K082118 · NPQ

Pathology · 417d

Cleared Jul 09, 2009

XPERT C. DIFFICILE

K091109 · LLH

Microbiology · 84d

Cleared Sep 29, 2008

XPERT MRSA/SA BLOOD CULTURE ASSAY

K082140 · NQX

Microbiology · 61d

Cleared Sep 24, 2008

XPERT MRSA/SA SSTI ASSAY

K080837 · NQX

Microbiology · 183d

Cleared Apr 17, 2007

XPERT MRSA

K070462 · NQX

Microbiology · 60d

Not Cleared Mar 16, 2007

XPERT EV, MODEL GXEV-100N-10

DEN070004 · OAI

Microbiology · 4d

Cleared Dec 08, 2006

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B

K062948 · NJR

Microbiology · 71d

Cleared Jul 25, 2006

XPERT, GENEXPERT DX SYSTEM

K060540 · NJR

Microbiology · 146d