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Euroimmun Us, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
37
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K193115EUROIMMUN Anti-BP230-CF ELISA (IgG)September 17, 2020
K183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgFebruary 28, 2019
K172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternMay 24, 2018
K172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternApril 20, 2018
K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternApril 20, 2018
K172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)December 10, 2017
K161513Anti-Borrelia burgdorferi US Westernblot (IgG)August 25, 2016
K153308EUROIMMUN Anti-West Nile Virus ELISA (IgM)August 12, 2016
K153303EUROIMMUN Anti-West Nile Virus ELISA (IgG)August 10, 2016
K142038EUROIMMUN LYME ELISA(IgG/IgM)May 4, 2015
K141827EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWAREApril 17, 2015
K140224EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)December 9, 2014
K132195EUROIMMUN ANTI-PLA2R ELISA (IGG)June 27, 2014
DEN140002EUROIMMUN ANTI-PLA2R IFAMay 29, 2014
K131791IFA 40: HEP-20-10February 26, 2014
K12366025-OH VITAMIN D ELISAJuly 17, 2013
K131185ANA SCREEN ELISA (IGG)July 15, 2013
K123261EUROIMMUN ANTI-NRNP/SM ELISA (IGG)June 12, 2013
K113439EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)April 12, 2013
K112996EUROIMMUN ANTI-ENA POOL ELISA (IGG)April 9, 2013