Medical Device Manufacturer · US , San Diego , CA

Quidel Corporation - FDA 510(k) Cleared Devices

37 submissions · 35 cleared · Since 2010

37

Total

35

Cleared

2

Denied

36 devices

26-36 of 36

Cleared Dec 16, 2014

SOFIA (R) STREP A+ FIA

Microbiology · 168d

Cleared Dec 10, 2014

AmpliVue Bordetella Assay

Microbiology · 33d

Cleared Oct 09, 2014

LYRA PARAINFLUENZA VIRUS ASSAY

Microbiology · 85d

Cleared Oct 09, 2014

LYRA ADENOVIRUS ASSAY

Microbiology · 85d

Cleared Jul 24, 2014

AMPLIVUE GAS ASSAY

Microbiology · 79d

Not Cleared Apr 16, 2014

LYRA DIRECT STREP ASSAY

DEN140005 · PGX

Microbiology · 22d

Cleared Mar 26, 2014

AMIPLIVUE HSV 1&2 ASSAY

Microbiology · 79d

Cleared Dec 20, 2013

AMPLIVUE GBS ASSAY

Microbiology · 36d

Cleared Jul 05, 2013

QUICK VUE INFLUENZA

Microbiology · 32d

Cleared Jun 17, 2013

SOFIA STREP A FIA

Microbiology · 189d

Cleared Dec 13, 2012

AMPLIVUE C. DIFFICILE ASSAY

Microbiology · 43d