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Data / Medical devices / Germany / EUROIMMUN Medizinische Labordiagnostika AG

EUROIMMUN Medizinische Labordiagnostika AG: FDA-registered device maker in Dassow Mecklenburg-Western Pomerania, Germany, 37 510(k) clearances

EUROIMMUN Medizinische Labordiagnostika AG is registered with the FDA (registration 3007361513) in Dassow Mecklenburg-Western Pomerania, Germany. It lists 59 device types. The FDA files 37 510(k) clearances under its listings, the newest dated September 17, 2020. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch EUROIMMUN Medizinische Labordiagnostika AG
FDA registration number
3007361513
Address
EUROIMMUN AG, Werkstrasse 1, Dassow Mecklenburg-Western Pomerania, Germany, D-23942
Owner or operator
EUROIMMUN Medizinische Labordiagnostika AG (10025212)
Roles
Manufacturer, Repackager or relabeler
First device listed
March 10, 2010
Registered through
2026
Brand names listed
17-OH Progesterone ELISA, 25-OH Vitamin D ELISA, ANA IFA: HEp-20-10, ANA Screen ELISA (IgG), Adjustment solution, Androstenedione ELISA, Anti-Adenovirus ELISA (IgG), Anti-BP180-NC16A-4X ELISA (IgG) and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Manufactureraccessdata.fda.gov
Anti-Dna Antibody (Enzyme-Labeled), Antigen, ControlLRM2Manufactureraccessdata.fda.gov
Anti-Dna Indirect Immunofluorescent Solid PhaseKTL2Manufactureraccessdata.fda.gov
Anti-Glutamate Receptor (Type Nmda) IfaOSK2Manufactureraccessdata.fda.gov
Anti-Phospholipase A2 ReceptorPGV2Manufactureraccessdata.fda.gov
Anti-Ribosomal P AntibodiesMQA2Manufactureraccessdata.fda.gov
Anti-Rnp Antibody, Antigen And ControlLKO2Manufactureraccessdata.fda.gov
Anti-Sm Antibody, Antigen And ControlLKP2Manufactureraccessdata.fda.gov
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)NHX2Manufactureraccessdata.fda.gov
Antibodies, GliadinMST2Manufactureraccessdata.fda.gov
Antigen, B. PertussisGOX1Manufactureraccessdata.fda.gov
Antigen, Fluorescent Antibody Test, Schistosoma MansoniGNH1Manufactureraccessdata.fda.gov
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, ControlDBM2Manufactureraccessdata.fda.gov
Antinuclear Antibody (Enzyme-Labeled), Antigen, ControlsLJM2Manufactureraccessdata.fda.gov
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, ControlDHN2Manufactureraccessdata.fda.gov
Antisera, Cf, Adenovirus 1-33GOA1Manufactureraccessdata.fda.gov
Antisera, Cf, Parainfluenza Virus 1-4GQT1Manufactureraccessdata.fda.gov
Antisera, Fluorescent, Brucella Spp.GSM2Manufactureraccessdata.fda.gov
Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6GNM1Manufactureraccessdata.fda.gov
Antisera, Hai, Influenza Virus A, B, CGNS1Manufactureraccessdata.fda.gov
Antisera, Positive Control, Echinococcus Spp.GPE1Manufactureraccessdata.fda.gov
Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune HepatitisNIY2Manufactureraccessdata.fda.gov
Autoantibodies, Endomysial(Tissue Transglutaminase)MVM2Manufactureraccessdata.fda.gov
Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)NBS2Manufactureraccessdata.fda.gov
Autoantibodies, Nuclear Body Protein, Sp100NUM2Manufactureraccessdata.fda.gov
Autoantibodies, Nuclear Pore Glycoprotein Gp210NRI2Manufactureraccessdata.fda.gov
Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230OEG2Manufactureraccessdata.fda.gov
Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)NBO2Manufactureraccessdata.fda.gov
Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical UsePIV2Manufactureraccessdata.fda.gov
Condensers, MicroscopeKEI1Manufactureraccessdata.fda.gov
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) ClinicaJQT1Manufactureraccessdata.fda.gov
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)MVJ2Manufactureraccessdata.fda.gov
Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information SystemNVV1Manufactureraccessdata.fda.gov
Elisa, Antibody, West Nile VirusNOP2Manufactureraccessdata.fda.gov
Elisa, Trichinella SpiralisMDT1Manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Mumps VirusLJY1Manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.LJZ1Manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubeola IggLJB1Manufactureraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Manufactureraccessdata.fda.gov
Extractable Antinuclear Antibody, Antigen And ControlLLL2Manufactureraccessdata.fda.gov
General Purpose ReagentPPM1Manufactureraccessdata.fda.gov
Instrumentation For Clinical Multiplex Test SystemsNSU2Manufactureraccessdata.fda.gov
Legionella, Spp., ElisaMJH2Manufactureraccessdata.fda.gov
Microscope, Fluorescence/U.V.IBK1Manufactureraccessdata.fda.gov
Mounting MediaLEB1Manufactureraccessdata.fda.gov
Radioimmunoassay, 17-HydroxyprogesteroneJLX1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, AndrostenedioneCIZ1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)JKC1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, EstroneCGF1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, PregnenoloneJNG1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Testosterones And DihydrotestosteroneCDZ1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Total Estrogens, NonpregnancyJMD1Repackager or relabeleraccessdata.fda.gov
Reagent, Borrelia Serological ReagentLSR2Manufactureraccessdata.fda.gov
Reagent, Coronavirus SerologicalQKONManufactureraccessdata.fda.gov
Reagents, CysticercosisMDJ1Manufactureraccessdata.fda.gov
Respiratory Syncytial Virus - ElisaMCE1Manufactureraccessdata.fda.gov
Station, Pipetting And Diluting, For Clinical UseJQW1Manufactureraccessdata.fda.gov
System, Test, Vitamin DMRG2Manufactureraccessdata.fda.gov
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)MOB2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 17, 2020K193115EUROIMMUN Anti-BP230-CF ELISA (IgG)OEGSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
February 28, 2019K183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)MVMSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
May 24, 2018K172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternMOBSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
April 20, 2018K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternKTLSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
April 20, 2018K172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternKTLSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
December 10, 2017K172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)LSRSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
August 25, 2016K161513Anti-Borrelia burgdorferi US Westernblot (IgG)LSRSubstantially EquivalentEuroimmun USaccessdata.fda.gov
August 12, 2016K153308EUROIMMUN Anti-West Nile Virus ELISA (IgM)NOPSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
August 10, 2016K153303EUROIMMUN Anti-West Nile Virus ELISA (IgG)NOPSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
May 4, 2015K142038EUROIMMUN LYME ELISA(IgG/IgM)LSRSubstantially EquivalentEuroimmun USaccessdata.fda.gov
April 17, 2015K141827EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWAREDHNSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
December 9, 2014K140224EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)LKOSubstantially EquivalentEuroimmun USaccessdata.fda.gov
June 27, 2014K132195EUROIMMUN ANTI-PLA2R ELISA (IGG)PGVSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
May 29, 2014DEN140002EUROIMMUN ANTI-PLA2R IFAPGVUnknownEuroimmun USaccessdata.fda.gov
February 26, 2014K131791IFA 40: HEP-20-10DHNSubstantially EquivalentEuroimmun USaccessdata.fda.gov
July 17, 2013K12366025-OH VITAMIN D ELISAMRGSubstantially EquivalentEuroimmun USaccessdata.fda.gov
July 15, 2013K131185ANA SCREEN ELISA (IGG)LJMSubstantially EquivalentEuroimmun USaccessdata.fda.gov
June 12, 2013K123261EUROIMMUN ANTI-NRNP/SM ELISA (IGG)LKOSubstantially EquivalentEuroimmun USaccessdata.fda.gov
April 12, 2013K113439EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)NIYSubstantially EquivalentEuroimmun USaccessdata.fda.gov
April 9, 2013K112996EUROIMMUN ANTI-ENA POOL ELISA (IGG)LLLSubstantially EquivalentEuroimmun USaccessdata.fda.gov
September 11, 2012K112223EUROIMMUN ANTI-LKM-1 ELISA(LGG)NBSSubstantially EquivalentEuroimmun USaccessdata.fda.gov
September 11, 2012K112221EUROIMMUN ANTI-SLA/LP ELISA(LGG)NIYSubstantially EquivalentEuroimmun USaccessdata.fda.gov
September 13, 2010K100017EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEMOSKSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
September 2, 2010K092736EUROIMMUN ANTI-M2-3E ELISA (IGG)DBMSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
September 2, 2010K091969EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)NBOSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
August 7, 2009K083053EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)MSTSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
July 28, 2009K083052EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)MSTSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
May 20, 2009K083850EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMSMOBSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
April 15, 2009K083381EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)LRMSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
April 7, 2009K082130EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)MOBSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
March 16, 2009K083615EUROIMMUN ANTI BP 180-4X ELISA (IGG)OEGSubstantially EquivalentEuroimmun Us, Inc.accessdata.fda.gov
December 31, 2007K070789EUROIMMUN ANTI-CCP ELISANHXSubstantially EquivalentEuroimmun Us, LLCaccessdata.fda.gov
May 22, 2007K070763EUROIMMUN ANA IFA: HEP-20-10DHNSubstantially EquivalentEuroimmun Us, LLCaccessdata.fda.gov
October 5, 2006K061408EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KITMVMSubstantially EquivalentEuroimmun Us, LLCaccessdata.fda.gov
September 8, 2006K060700EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.MOBSubstantially EquivalentEuroimmun Us, LLCaccessdata.fda.gov
February 16, 2006K051489EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUMMOBSubstantially EquivalentEuroimmun Us, LLCaccessdata.fda.gov
August 18, 2003K030730FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KITCDZSubstantially EquivalentDiagnostics Biochem Canada, Inc.accessdata.fda.gov

Compare with other makers

Updated September 17, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.