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Focus Diagnostics Inc

12 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human s recall (Z-1685-2017)Focus Diagnostics Inc2017-03-27
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quan recall (Z-1686-2017)Focus Diagnostics Inc2017-03-27
Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL145 recall (Z-1272-2016)Focus Diagnostics Inc2016-04-02
Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, recall (Z-1273-2016)Focus Diagnostics Inc2016-04-02
Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, recall (Z-1274-2016)Focus Diagnostics Inc2016-04-02
Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro d recall (Z-0238-2016)Focus Diagnostics Inc2015-11-06
STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in recall (Z-1454-2015)Focus Diagnostics Inc2015-04-17
Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & recall (Z-1958-2014)Focus Diagnostics Inc2014-07-01
Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential d recall (Z-1144-2014)Focus Diagnostics Inc2014-03-05
Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B recall (Z-0846-2014)Focus Diagnostics Inc2014-01-28
West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122 recall (Z-0182-2013)Focus Diagnostics Inc2012-10-31
HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the p recall (Z-1764-2008)Focus Diagnostics Inc2008-08-17

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Every clearance here is in the API, with alerts when new ones post.