Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003268355

FEI Number

3003268355

Entity Name

EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG

City/State/Country

Luebeck Schleswig-Holstein, DE

Establishment Address

EUROIMMUN AG, Seekamp 31, Luebeck Schleswig-Holstein D-23560, DE

Establishment Type(s)

Manufacture 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IFA 40: HEp-20-10 EUROPattern EUROPattern Classifier EUROPattern Microscope Anti-West Nile Virus ELISA (IgM) IFA: Granulocytes (EOH) IFA: Granulocyte Mosaic 2 IFA: Granulocytes (HCHO) IFA: Granulocyte Mosaic 13 Anti-Influenza A Virus ELISA (IgG) Anti-Influenza B Virus ELISA (IgG) Anti-Legionella pneumophila ELISA (IgG) 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 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-SARS-CoV-2 ELISA (IgG) Anti-Borrelia burgdorferi US WESTERNBLOT (IgG) IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern EUROPattern Classifier Anti-Schistosoma mansoni IFA (IgG) Anti-Schistosoma ELISA (IgG) EUROLineScan Anti-PR3-hn-hr ELISA (IgG) Anti-Echinococcus ELISA (IgG) EUROLINE-WB Anti-Echinococcus (IgG) EUROLINE Bordetella pertussis (IgG) Anti-LKM-1 ELISA (IgG) Anti-RSV ELISA (IgG) Anti-BP180-NC16A-4X ELISA (IgG) Anti-West Nile Virus ELISA (IgG) IFA: Crithidia luciliae (anti-dsDNA) EUROPattern EUROPattern Classifier Anti-CCP ELISA (IgG) Anti-Brucella abortus ELISA (IgG) Anti-Desmoglein 1 ELISA (IgG) Anti-Desmoglein 3 ELISA (IgG) Anti-Mumps Virus AT ELISA (IgG) Anti-Mumps Virus ELISA (IgG) Anti-Adenovirus ELISA (IgG) Anti-tissue Transglutaminase ELISA (IgG) Anti-tissue Transglutaminase ELISA (IgA) Anti-BP230-CF ELISA (IgG) EUROBlotMaster 44 EUROBlotMaster EUROLabWorkstation IFA Sprinter XL UNIQO 160 IF Sprinter Anti-Parainfluenza Viruses Pool ELISA (IgG) EURORealTime SARS-CoV-2 UNIQO 160 Anti-Glutamate receptor (type NMDA) IFA ANA Screen ELISA (IgG) Anti-dsDNA-NcX ELISA (IgG) Anti-ENA Pool ELISA (IgG) Anti-Mycoplasma pneumoniae ELISA (IgG) EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) Lyme ELISA (IgG/IgM) EUROPLUS Granulocyte Mosaic 22 EUROPLUS Granulocyte Mosaic 32 IFA Mosaic: Coxsackie virus B Types (IgG) IFA Mosaic: Coxsackie virus A Types (IgG) IFA Mosaic: Coxsackie virus (IgG) IFA Mosaic: Coxsackie virus Type A7 / Type B1 (IgG) Anti-Gliadin (GAF-3X) ELISA (IgA) 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) 25-OH Vitamin D ELISA Anti-Toxocara ELISA (IgG)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
NOP	Elisa, Antibody, West Nile Virus	Microbiology	Class 2	866.3940	2016-09-14
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2012-08-30
GNS	Antisera, Hai, Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2016-04-07
MJH	Legionella, Spp., Elisa	Microbiology	Class 2	866.3300	2016-04-07
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2016-04-07
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
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-03-30
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	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
GNH	Antigen, Fluorescent Antibody Test, Schistosoma Mansoni	Microbiology	Class 1	866.3600	2016-04-07
JQT	Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica	Clinical Chemistry	Class 1	862.2400	2016-04-07
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2012-08-30
GPE	Antisera, Positive Control, Echinococcus Spp.	Microbiology	Class 1	866.3200	2016-04-11
GOX	Antigen, B. Pertussis	Microbiology	Class 1	866.3065	2016-04-07
NBS	Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)	Immunology	Class 2	866.5660	2012-09-18
MCE	Respiratory Syncytial Virus - Elisa	Microbiology	Class 1	866.3480	2016-04-07
OEG	Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230	Immunology	Class 2	866.5660	2012-08-30
NOP	Elisa, Antibody, West Nile Virus	Microbiology	Class 2	866.3940	2016-09-14
KTL	Anti-Dna Indirect Immunofluorescent Solid Phase	Immunology	Class 2	866.5100	2018-04-24
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2018-04-24
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2010-03-10
GSM	Antisera, Fluorescent, Brucella Spp.	Microbiology	Class 2	866.3085	2016-04-07
NBO	Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)	Immunology	Class 2	866.5660	2012-08-30
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Microbiology	Class 1	866.3380	2016-04-07
GOA	Antisera, Cf, Adenovirus 1-33	Microbiology	Class 1	866.3020	2016-04-07
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2019-03-06
OEG	Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230	Immunology	Class 2	866.5660	2020-09-23
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2016-09-14
GQT	Antisera, Cf, Parainfluenza Virus 1-4	Microbiology	Class 1	866.3400	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
OSK	Anti-Glutamate Receptor (Type Nmda) Ifa	Immunology	Class 2	866.5660	2012-08-30
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2013-07-18
LRM	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	Immunology	Class 2	866.5100	2012-08-30
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2013-04-17
LJZ	Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.	Microbiology	Class 1	866.3375	2016-04-07
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
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
GNM	Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6	Microbiology	Class 1	866.3145	2016-04-07
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2012-08-30
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
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2013-07-19
MDJ	Reagents, Cysticercosis	Microbiology	Class 1	866.3200	2020-07-13

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
3007361513	EUROIMMUN Medizinische Labordiagnostika AG	Dassow Mecklenburg-Western Pomerania, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880742	Inova Diagnostics, Inc.	NOVA LITE(TM) DSDNA	1988-03-25
K780273	Flow Laboratories, Inc.	INFLUENZA HI PRESERUM	1978-02-28
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K203599	Immuno Concepts, N.A. , Ltd.	Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System	2023-05-26
K915332	Ciba Corning Diagnostics Corp.	MODEL 795 FLUOROMETER/DENSITOMETER	1992-02-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Z-0010-2019	Radiometer America Inc	1	ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Similar Registrations

Registration Number	Establishment Name	Location
3007118747	EUROIMMUN US INC.	Mountain Lakes, NJ, US
2026994	INOVA DIAGNOSTICS, INC.	SAN DIEGO, CA, US
3007361513	EUROIMMUN Medizinische Labordiagnostika AG	Dassow Mecklenburg-Western Pomerania, DE
2242436	ZEUS SCIENTIFIC LLC	BRANCHBURG, NJ, US
3012348571	INSTRUMENTATION LABORATORY SPA	Roncello Lombardy, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003268355. Last updated year: 2026. Please use registration number 3003268355 when referencing this establishment in official correspondence.