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Euroimmun Us, Inc.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories6
Latest Approval2020-09-17
TypeNumberDevice NameCodeDate
510(k) K193115 EUROIMMUN Anti-BP230-CF ELISA (IgG) OEG 2020-09-17 View
510(k) K183313 EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) MVM 2019-02-28 View
510(k) K172582 EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern MOB 2018-05-24 View
510(k) K172244 EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern KTL 2018-04-20 View
510(k) K172252 EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern KTL 2018-04-20 View
510(k) K172722 Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) LSR 2017-12-10 View
510(k) K153308 EUROIMMUN Anti-West Nile Virus ELISA (IgM) NOP 2016-08-12 View
510(k) K153303 EUROIMMUN Anti-West Nile Virus ELISA (IgG) NOP 2016-08-10 View