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Euroimmun Us, Inc.

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K193115 EUROIMMUN Anti-BP230-CF ELISA (IgG)OEG2020-09-17 View
510(k) K183313 EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)MVM2019-02-28 View
510(k) K172582 EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternMOB2018-05-24 View
510(k) K172244 EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternKTL2018-04-20 View
510(k) K172252 EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternKTL2018-04-20 View
510(k) K172722 Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)LSR2017-12-10 View
510(k) K153308 EUROIMMUN Anti-West Nile Virus ELISA (IgM)NOP2016-08-12 View
510(k) K153303 EUROIMMUN Anti-West Nile Virus ELISA (IgG)NOP2016-08-10 View
510(k) K100017 EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEMOSK2010-09-13 View
510(k) K091969 EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)NBO2010-09-02 View
510(k) K092736 EUROIMMUN ANTI-M2-3E ELISA (IGG)DBM2010-09-02 View
510(k) K083053 EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)MST2009-08-07 View
510(k) K083052 EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)MST2009-07-28 View
510(k) K083850 EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMSMOB2009-05-20 View
510(k) K083381 EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)LRM2009-04-15 View
510(k) K082130 EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)MOB2009-04-07 View
510(k) K083615 EUROIMMUN ANTI BP 180-4X ELISA (IGG)OEG2009-03-16 View
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