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Quidel Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
93
Inspections
0
Compliance Actions
0

Known Names

quidel corporation, quidel

Recent 510(k) Clearances

K-NumberDeviceDate
K131813QUIDEL MOLECULAR RSV + HMPV ASSAYSeptember 6, 2013
K131728QUIDEL MOLECULAR INFLUENZA A + B ASSAYAugust 29, 2013
K130398SOFIA(R) RSV FIAAugust 13, 2013
K131166SOFIA(R) HCG FIAAugust 2, 2013
K131606SOFIA INFLUENZA A+B FIAJuly 5, 2013
K131619QUICKVUE INFLUENZA A+BJune 28, 2013
K123998QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAYMarch 8, 2013
K122189QUIDEL MOLECULAR RSV + HMPV ASSAYMarch 8, 2013
K113777QUIDEL MOLECULAR INFLUENZA A+BMarch 15, 2012
K112172QUIDEL MOLECULAR INFLUENZA A + B ASSAYDecember 22, 2011
K112490QUIDEL MOLECULAR HMPV ASSAYDecember 15, 2011
K112177SOFIA ANALYZER AND INFLUENZA A+B FIAOctober 24, 2011
K101918QUICKVUE RSV 10September 24, 2010
K092698QUICKVUE INFLUENZA A+B TESTSeptember 15, 2009
K070747QUICK VUE RSV TEST, MODELS 20193, 20199April 23, 2007
K061008QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199September 8, 2006
K053146QUICKVUE INFLUENZA A + B TESTDecember 14, 2005
K040008QUICKVUE ADVANCE PH AND AMINES GLL TESTApril 29, 2004
K031899QUICKVUE INFLUENZA A+B TESTSeptember 11, 2003
K022851PH AND AMINES EXTERNAL CONTROL SETSeptember 27, 2002