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Focus Diagnostics Inc

FDA Regulatory Profile

Summary

Total Recalls
11 (2 Class I)
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1686-2017Class IILegionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating hFebruary 15, 2017
Z-1685-2017Class IILegionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibFebruary 15, 2017
Z-1274-2016Class ISimplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) February 10, 2016
Z-1272-2016Class ISimplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) ModeFebruary 10, 2016
Z-1273-2016Class IISimplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) February 10, 2016
Z-0238-2016Class IIFocus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnosticOctober 2, 2015
Z-1454-2015Class IISTRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serMarch 15, 2015
Z-1958-2014Class IISimplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413  Simplexa" Flu A/B & RSMay 15, 2014
Z-1144-2014Class IISimplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis oFebruary 4, 2014
Z-0846-2014Class IISimplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV January 10, 2014
Z-0182-2013Class IIIWest Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 1October 3, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K152408Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control PackSeptember 21, 2015
K150962Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackAugust 28, 2015
K143651Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackMarch 18, 2015
K142365Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control PackDecember 5, 2014
K141458SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACKJuly 1, 2014
DEN130049SIMPLEXA HSV 1&2 DIRECTMarch 21, 2014
K120986STRATIFY JCV DXSELECTAugust 16, 2012
K120413SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACKJuly 13, 2012
K113433SIMPLEXA C. DIFFICILE UNIVERSAL DIRECTApril 4, 2012
DEN120008STRATIFY JCV(TM) ANTIBODYJanuary 20, 2012
K102170SIMPLEXA FLU A/B & RSVNovember 24, 2010
K1023143M INTEGRATED CYCLER (110V) & (220V)October 29, 2010
K100148SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500May 24, 2010
K073381PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600MAugust 4, 2008
K073382PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500GJuly 28, 2008
K071511PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900GOctober 5, 2007
K071510HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950September 24, 2007
K062543HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900GFebruary 1, 2007