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Quidel Corp.

FDA 510(k) & PMA Approved Devices — 93 products

Total Devices93
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K131813 QUIDEL MOLECULAR RSV + HMPV ASSAYOCC2013-09-06 View
510(k) K131728 QUIDEL MOLECULAR INFLUENZA A + B ASSAYOZE2013-08-29 View
510(k) K130398 SOFIA(R) RSV FIAGQG2013-08-13 View
510(k) K131166 SOFIA(R) HCG FIAJHI2013-08-02 View
510(k) K131606 SOFIA INFLUENZA A+B FIAGNX2013-07-05 View
510(k) K131619 QUICKVUE INFLUENZA A+BGNX2013-06-28 View
510(k) K122189 QUIDEL MOLECULAR RSV + HMPV ASSAYOEM2013-03-08 View
510(k) K123998 QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAYOZN2013-03-08 View
510(k) K113777 QUIDEL MOLECULAR INFLUENZA A+BOZE2012-03-15 View
510(k) K112172 QUIDEL MOLECULAR INFLUENZA A + B ASSAYOCC2011-12-22 View
510(k) K112490 QUIDEL MOLECULAR HMPV ASSAYOEM2011-12-15 View
510(k) K112177 SOFIA ANALYZER AND INFLUENZA A+B FIAPSZ2011-10-24 View
510(k) K101918 QUICKVUE RSV 10GQG2010-09-24 View
510(k) K092698 QUICKVUE INFLUENZA A+B TESTPSZ2009-09-15 View
510(k) K070747 QUICK VUE RSV TEST, MODELS 20193, 20199GQG2007-04-23 View
510(k) K061008 QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199MCE2006-09-08 View
510(k) K053146 QUICKVUE INFLUENZA A + B TESTPSZ2005-12-14 View
510(k) K040008 QUICKVUE ADVANCE PH AND AMINES GLL TESTCEN2004-04-29 View
510(k) K031899 QUICKVUE INFLUENZA A+B TESTPSZ2003-09-11 View
510(k) K022851 PH AND AMINES EXTERNAL CONTROL SETJJY2002-09-27 View
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