EUROIMMUN Medizinische Labordiagnostika AG

FDA Device Registration & Listing · Dassow Mecklenburg-Western Pomerania, DE · Registration 3007361513

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007361513
FEI Number
3007361513
Entity Name
EUROIMMUN Medizinische Labordiagnostika AG
City/State/Country
Dassow Mecklenburg-Western Pomerania, DE
Establishment Address
EUROIMMUN AG, Werkstrasse 1, Dassow Mecklenburg-Western Pomerania D-23942, DE
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
EUROIMMUN Medizinische Labordiagnostika AG (Owner Number: 10025212)
Owner / Operator Contact Address
EUROIMMUN AG, Seekamp 31, Luebeck, DE-SH D-23560, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ANA Screen ELISA (IgG) ELISA wash buffer 10x conc. FITC-labelled anti-human IgA with Evans Blue FITC-labelled Avidin (biotin affine) FITC-labelled anti-human IgG (primate absorbed) FITC-labelled anti-human IgG with Evans Blue Adjustment solution FITC-labelled anti-human IgA PBS (IIFT) EUROArray wash buffer set Sample buffer 2, Crithidia luciliae sensitive (IFA) ELISA sample buffer ELISA Stop solution Secondary reagents immunoblot (IgM) ELISA chromogen/substrate solution Secondary reagents immunoblot (IgG) Sample buffer (IIFT) WASH REAGENT 2 EUROSORB (IFA) Biotin-labelled anti-human IgG FITC-labelled anti-human IgG ELISA enzyme conjugate, anti-human IgA Tween 20 (IFA) PBS-Tween (IFA) FITC-labelled anti-human IgG with propidium iodide for EUROPattern EUROArrayProcessor Pre-PCR Software EUROArrayProcessor EUROArrayProcessor Reagent tray set EUROArrayScanner EUROArrayScan IFA: Granulocytes (EOH) IFA: Granulocyte Mosaic 2 IFA: Granulocytes (HCHO) IFA: Granulocyte Mosaic 13 Anti-Measles Virus ELISA (IgG) Anti-Measles Virus ELISA 2 (IgG) Mounting medium (IIFT) Anti-BP230-CF ELISA (IgG) Anti-Legionella pneumophila ELISA (IgG) EURORealTime SARS-CoV-2 UNIQO 160 Anti-SARS-CoV-2 ELISA (IgG) Anti-West Nile Virus ELISA (IgM) 25-OH Vitamin D ELISA Anti-Echinococcus ELISA (IgG) EUROLINE-WB Anti-Echinococcus (IgG) EUROBlotMaster 44 EUROBlotMaster EUROLabWorkstation IFA Sprinter XL UNIQO 160 IF Sprinter IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern EUROPattern Classifier EUROPLUS Granulocyte Mosaic 22 EUROPLUS Granulocyte Mosaic 32 Anti-SLA/LP ELISA (IgG) Free Testosterone ELISA Anti-nRNP/Sm ELISA (IgG) Anti-SS-A ELISA (IgG) Anti-SS-B ELISA (IgG) Anti-Centromeres ELISA (IgG) Anti-ribosomal P Proteins ELISA (IgG) Anti-Scl-70 ELISA (IgG) Anti-Jo-1 ELISA (IgG) Anti-Sm ELISA (IgG) Androstenedione ELISA Anti-LKM-1 ELISA (IgG) Anti-Brucella abortus ELISA (IgG) Anti-Glutamate receptor (type NMDA) IFA Anti-Adenovirus ELISA (IgG) Coded reagent tray for slides with 50 fields TITERPLANE set for the incubation of slides with 50 fields Reagent tray for incubation of slides Incubation tray 44 channels, black Coded glass plates for the incubation of slides with 10 fields TITERPLANE set for the incubation of slides with 10 fields Coded glass plates for the incubation of slides with 50 fields Coded reagent tray for slides with 10 fields Anti-Mumps Virus AT ELISA (IgG) Anti-Mumps Virus ELISA (IgG) EUROLINE ENA ProfilePlus 4 (IgG) EUROLINE ENA Profile 9 Ag (IgG) Anti-Schistosoma mansoni IFA (IgG) Anti-Schistosoma ELISA (IgG) 17-OH Progesterone ELISA Lyme ELISA (IgG/IgM) Anti-PR3-hn-hr ELISA (IgG) Anti-MPO ELISA (IgG) EUROLabOffice EUROLabOffice 4 Anti-M2-3E ELISA (IgG) Anti-Desmoglein 1 ELISA (IgG) Anti-Desmoglein 3 ELISA (IgG) Anti-West Nile Virus ELISA (IgG) Anti-ENA Pool ELISA (IgG) EUROStar III Plus EUROPicture EUROStar IV Plus Anti-tissue Transglutaminase ELISA (IgG) Anti-tissue Transglutaminase ELISA (IgA) EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) Anti-Strongyloides ELISA (IgG) IFA: Oesophagus (Monkey) IgA EUROPattern IFA: Oesophagus (Monkey) IgA IFA 40: HEp-20-10 EUROPattern EUROPattern Classifier EUROPattern Microscope Anti-RSV ELISA (IgG) EUROLINE Bordetella pertussis (IgG) Pregnenolone ELISA EUROIMMUN Analyzer I-2P EUROBlotOne EUROIMMUN Analyzer I EUROLabWorkstation ELISA System liquid concentrate Sprinter XL Device Qualification Test Kit EUROLabWorkstation ELISA IF Sprinter Device Qualification Test Kit EUROLabWorkstation IFA Device Qualification Test Kit EUROLabLiquidHandler Device Qualification Test Kit EUROIMMUN Analyzer I / I-2P Total Estrogens ELISA Anti-Toxocara ELISA (IgG) ANA IFA: HEp-20-10 Anti-Gliadin (GAF-3X) ELISA (IgA) IFA: Granulocyte Mosaic 2 EUROPattern EUROPLUS Granulocyte Mosaic 22 EUROPattern EUROPLUS Granulocyte Mosaic 25 EUROPattern IFA: Granulocyte Mosaic 13 EUROPattern EUROPLUS Granulocyte Mosaic 32 EUROPattern EUROPattern Classifier Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) Estrone ELISA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2013-07-18
PPM General Purpose Reagent Pathology Class 1 864.4010 2022-08-24
NSU Instrumentation For Clinical Multiplex Test Systems Clinical Chemistry Class 2 862.2570 2022-08-24
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) Immunology Class 2 866.5660 2012-08-30
LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg Microbiology Class 1 866.3520 2016-04-07
LEB Mounting Media Pathology Class 1 864.4010 2019-01-09
OEG Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 Immunology Class 2 866.5660 2020-09-23
MJH Legionella, Spp., Elisa Microbiology Class 2 866.3300 2016-04-07
QJR Reagents, 2019-Novel Coronavirus Nucleic Acid Unknown Class N N/A 2020-08-04
IBK Microscope, Fluorescence/U.V. Pathology Class 1 864.3600 2022-08-24
QKO Reagent, Coronavirus Serological Unknown Class N N/A 2020-03-30
NOP Elisa, Antibody, West Nile Virus Microbiology Class 2 866.3940 2016-09-14
MRG System, Test, Vitamin D Clinical Chemistry Class 2 862.1825 2013-07-19
GPE Antisera, Positive Control, Echinococcus Spp. Microbiology Class 1 866.3200 2016-04-11
JQW Station, Pipetting And Diluting, For Clinical Use Clinical Chemistry Class 1 862.2750 2016-09-14
PIV Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use Immunology Class 2 866.4750 2018-04-24
KTL Anti-Dna Indirect Immunofluorescent Solid Phase Immunology Class 2 866.5100 2018-04-24
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) Immunology Class 2 866.5660 2012-08-30
NIY Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis Immunology Class 2 866.5660 2012-09-18
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2021-01-13
LKO Anti-Rnp Antibody, Antigen And Control Immunology Class 2 866.5100 2013-06-17
MQA Anti-Ribosomal P Antibodies Immunology Class 2 866.5100 2013-06-17
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2013-06-17
LKP Anti-Sm Antibody, Antigen And Control Immunology Class 2 866.5100 2013-06-17
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2013-06-17
CIZ Radioimmunoassay, Androstenedione Clinical Chemistry Class 1 862.1075 2020-07-13
NBS Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) Immunology Class 2 866.5660 2012-09-18
GSM Antisera, Fluorescent, Brucella Spp. Microbiology Class 2 866.3085 2016-04-07
OSK Anti-Glutamate Receptor (Type Nmda) Ifa Immunology Class 2 866.5660 2012-08-30
GOA Antisera, Cf, Adenovirus 1-33 Microbiology Class 1 866.3020 2016-04-07
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2017-11-10
LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus Microbiology Class 1 866.3380 2016-04-07
MQA Anti-Ribosomal P Antibodies Immunology Class 2 866.5100 2014-12-15
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2014-12-15
LKP Anti-Sm Antibody, Antigen And Control Immunology Class 2 866.5100 2014-12-15
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2014-12-15
LKO Anti-Rnp Antibody, Antigen And Control Immunology Class 2 866.5100 2014-12-15
GNH Antigen, Fluorescent Antibody Test, Schistosoma Mansoni Microbiology Class 1 866.3600 2016-04-07
JLX Radioimmunoassay, 17-Hydroxyprogesterone Clinical Chemistry Class 1 862.1395 2020-07-13
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2015-05-05
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) Immunology Class 2 866.5660 2012-08-30
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) Immunology Class 2 866.5660 2012-08-30
NVV Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System Clinical Chemistry Class 1 862.2100 2016-04-07
DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5090 2012-08-30
NBO Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) Immunology Class 2 866.5660 2012-08-30
NOP Elisa, Antibody, West Nile Virus Microbiology Class 2 866.3940 2016-09-14
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2013-04-17
KEI Condensers, Microscope Pathology Class 1 864.3600 2016-04-07
MVM Autoantibodies, Endomysial(Tissue Transglutaminase) Immunology Class 2 866.5660 2019-03-06
NBS Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) Immunology Class 2 866.5660 2013-04-17
NRI Autoantibodies, Nuclear Pore Glycoprotein Gp210 Immunology Class 2 866.5090 2013-04-17
DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5090 2013-04-17
NIY Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis Immunology Class 2 866.5660 2013-04-17
NUM Autoantibodies, Nuclear Body Protein, Sp100 Immunology Class 2 866.5090 2013-04-17
MDT Elisa, Trichinella Spiralis Microbiology Class 1 866.3850 2017-11-10
MVM Autoantibodies, Endomysial(Tissue Transglutaminase) Immunology Class 2 866.5660 2012-08-30
PIV Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use Immunology Class 2 866.4750 2015-05-05
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2015-05-05
MCE Respiratory Syncytial Virus - Elisa Microbiology Class 1 866.3480 2016-04-07
GOX Antigen, B. Pertussis Microbiology Class 1 866.3065 2016-04-07
JNG Radioimmunoassay, Pregnenolone Clinical Chemistry Class 1 862.1615 2021-03-11
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2016-04-07
JMD Radioimmunoassay, Total Estrogens, Nonpregnancy Clinical Chemistry Class 1 862.1275 2020-07-13
MDJ Reagents, Cysticercosis Microbiology Class 1 866.3200 2020-07-13
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2012-08-30
MST Antibodies, Gliadin Immunology Class 2 866.5750 2012-08-30
MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) Immunology Class 2 866.5660 2018-05-28
PIV Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use Immunology Class 2 866.4750 2018-05-28
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) Immunology Class 2 866.5660 2018-05-28
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2017-12-13
CGF Radioimmunoassay, Estrone Clinical Chemistry Class 1 862.1280 2021-02-16

Official Correspondent

Stephan Maihold

US Agent Details

Faith Du Email: ra-us@euroimmun.us Phone: (973) 6561000

Related Public Records

Same Entity

EUROIMMUN Medizinische Labordiagnostika AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003268355 EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG Luebeck Schleswig-Holstein, DE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007361513. Last updated year: 2026. Please use registration number 3007361513 when referencing this establishment in official correspondence.
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