FDA Registration
Active
🇩🇪 Germany
EUROIMMUN Medizinische Labordiagnostika AG
Reg #: 3007361513
·
FEI: 3007361513
·
Expires 2026
Products
60
Proprietary Names
148
Establishment Types
2
Classifications
60
Registration Details
- Registration Name
- EUROIMMUN Medizinische Labordiagnostika AG
- Registration Number
- 3007361513
- FEI Number
- 3007361513
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- EUROIMMUN AG, Werkstrasse 1
- City
- Dassow Mecklenburg-Western Pomerania
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K131185
Owner / Operator
- Firm Name
- EUROIMMUN Medizinische Labordiagnostika AG
- Operator Number
- 10025212
- Address
- EUROIMMUN AG, Seekamp 31
- City
- Luebeck
- State
- Schleswig-Holstein
- Postal Code
- D-23560
- Country
- DE
- Correspondent
- Stephan Maihold
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | Class 2 | Immunology | No | 2013-07-18 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2022-08-24 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2022-08-24 |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | Class 2 | Immunology | No | 2012-08-30 |
| Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | LJB | Class 1 | Microbiology | No | 2016-04-07 |
| Mounting Media | LEB | Class 1 | Pathology | No | 2019-01-09 |
| Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 | OEG | Class 2 | Immunology | No | 2020-09-23 |
| Legionella, Spp., Elisa | MJH | Class 2 | Microbiology | No | 2016-04-07 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-08-04 |
| Microscope, Fluorescence/U.V. | IBK | Class 1 | Pathology | No | 2022-08-24 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2020-03-30 |
| Elisa, Antibody, West Nile Virus | NOP | Class 2 | Microbiology | No | 2016-09-14 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2013-07-19 |
| Antisera, Positive Control, Echinococcus Spp. | GPE | Class 1 | Microbiology | No | 2016-04-11 |
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2016-09-14 |
| Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use | PIV | Class 2 | Immunology | No | 2018-04-24 |
| Anti-Dna Indirect Immunofluorescent Solid Phase | KTL | Class 2 | Immunology | No | 2018-04-24 |
| Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis | NIY | Class 2 | Immunology | No | 2012-09-18 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2021-01-13 |
| Anti-Rnp Antibody, Antigen And Control | LKO | Class 2 | Immunology | No | 2013-06-17 |
| Anti-Ribosomal P Antibodies | MQA | Class 2 | Immunology | No | 2013-06-17 |
| Anti-Sm Antibody, Antigen And Control | LKP | Class 2 | Immunology | No | 2013-06-17 |
| Extractable Antinuclear Antibody, Antigen And Control | LLL | Class 2 | Immunology | No | 2013-06-17 |
| Radioimmunoassay, Androstenedione | CIZ | Class 1 | Clinical Chemistry | No | 2020-07-13 |
| Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) | NBS | Class 2 | Immunology | No | 2012-09-18 |
| Antisera, Fluorescent, Brucella Spp. | GSM | Class 2 | Microbiology | No | 2016-04-07 |
| Anti-Glutamate Receptor (Type Nmda) Ifa | OSK | Class 2 | Immunology | No | 2012-08-30 |
| Antisera, Cf, Adenovirus 1-33 | GOA | Class 1 | Microbiology | No | 2016-04-07 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2017-11-10 |
| Enzyme Linked Immunoabsorbent Assay, Mumps Virus | LJY | Class 1 | Microbiology | No | 2016-04-07 |
| Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | GNH | Class 1 | Microbiology | No | 2016-04-07 |
| Radioimmunoassay, 17-Hydroxyprogesterone | JLX | Class 1 | Clinical Chemistry | No | 2020-07-13 |
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2015-05-05 |
| Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System | NVV | Class 1 | Clinical Chemistry | No | 2016-04-07 |
| Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | DBM | Class 2 | Immunology | No | 2012-08-30 |
| Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) | NBO | Class 2 | Immunology | No | 2012-08-30 |
| Condensers, Microscope | KEI | Class 1 | Pathology | No | 2016-04-07 |
| Autoantibodies, Endomysial(Tissue Transglutaminase) | MVM | Class 2 | Immunology | No | 2019-03-06 |
| Autoantibodies, Nuclear Pore Glycoprotein Gp210 | NRI | Class 2 | Immunology | No | 2013-04-17 |
| Autoantibodies, Nuclear Body Protein, Sp100 | NUM | Class 2 | Immunology | No | 2013-04-17 |
| Elisa, Trichinella Spiralis | MDT | Class 1 | Microbiology | No | 2017-11-10 |
| Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | DHN | Class 2 | Immunology | No | 2015-05-05 |
| Respiratory Syncytial Virus - Elisa | MCE | Class 1 | Microbiology | No | 2016-04-07 |
| Antigen, B. Pertussis | GOX | Class 1 | Microbiology | No | 2016-04-07 |
| Radioimmunoassay, Pregnenolone | JNG | Class 1 | Clinical Chemistry | No | 2021-03-11 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2016-04-07 |
| Radioimmunoassay, Total Estrogens, Nonpregnancy | JMD | Class 1 | Clinical Chemistry | No | 2020-07-13 |
| Reagents, Cysticercosis | MDJ | Class 1 | Microbiology | No | 2020-07-13 |
| Antibodies, Gliadin | MST | Class 2 | Immunology | No | 2012-08-30 |
| Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | MVJ | Class 2 | Immunology | No | 2018-05-28 |
| Radioimmunoassay, Estrone | CGF | Class 1 | Clinical Chemistry | No | 2021-02-16 |
| Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 | GNM | Class 1 | Microbiology | No | 2016-04-07 |
| Anti-Phospholipase A2 Receptor | PGV | Class 2 | Microbiology | No | 2014-06-03 |
| Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | NHX | Class 2 | Immunology | No | 2010-03-10 |
| Antisera, Hai, Influenza Virus A, B, C | GNS | Class 1 | Microbiology | No | 2016-04-07 |
| Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | LRM | Class 2 | Immunology | No | 2012-08-30 |
| Antisera, Cf, Parainfluenza Virus 1-4 | GQT | Class 1 | Microbiology | No | 2016-04-07 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | Class 1 | Clinical Chemistry | No | 2020-07-13 |
| Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | LJZ | Class 1 | Microbiology | No | 2016-04-07 |
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | JQT | Class 1 | Clinical Chemistry | No | 2016-04-07 |
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
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 Microscope
Anti-RSV ELISA (IgG)
EUROLINE Bordetella pertussis (IgG)
Pregnenolone ELISA
EUROIMMUN Analyzer I-2P
EUROBlotOne
EUROIMMUN Analyzer I
EUROLabWorkstation ELISA
System liquid concentrate
Device Qualification Test Kit EUROLabWorkstation ELISA
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
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
Estrone ELISA
Anti-Borrelia burgdorferi US WESTERNBLOT (IgG)
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-PLA2R IFA
Anti-PLA2R ELISA (IgG)
Anti-BP180-NC16A-4X ELISA (IgG)
Anti-CCP ELISA (IgG)
Anti-Influenza A Virus ELISA (IgG)
Anti-Influenza B Virus ELISA (IgG)
IFA 40: HEp-20-10
Anti-dsDNA-NcX ELISA (IgG)
Anti-Parainfluenza Viruses Pool ELISA (IgG)
Anti-Gliadin (GAF-3X) ELISA (IgG)
Dehydroepiandrosterone (DHEA) ELISA
Anti-Mycoplasma pneumoniae ELISA (IgG)
IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
EUROLineScan
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device