BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EUROIMMUN US INC.

    Reg #: 3007118747 · FEI: 3007118747 · Expires 2026
    View on FDA
    Products
    77
    Proprietary Names
    224
    Establishment Types
    2
    Classifications
    77

    Registration Details

    Registration Name
    EUROIMMUN US INC.
    Registration Number
    3007118747
    FEI Number
    3007118747
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1 Bloomfield Ave
    City
    Mountain Lakes
    State
    NJ
    ZIP
    07046
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111650

    Owner / Operator

    Firm Name
    EUROIMMUN US Inc.
    Operator Number
    10025673
    Address
    1 Bloomfield Ave.
    City
    Mountain Lakes
    State
    NJ
    Postal Code
    07046
    Country
    US

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Antisera, Hai, Influenza Virus A, B, C GNS
    System, Test, Vitamin D MRG
    Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control LRM
    Elisa, Antibody, West Nile Virus NOP
    Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) NBO
    Elisa, Trichinella Spiralis MDT
    Station, Pipetting And Diluting, For Clinical Use JQW
    Radioimmunoassay, Human Growth Hormone CFL
    Antisera, Cf, Adenovirus 1-33 GOA
    Antibodies, Gliadin MST
    Radioimmunoassay, Parathyroid Hormone CEW
    Calibrator, Secondary JIT
    Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use PIV
    Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) MVJ
    Test System, Antineutrophil Cytoplasmic Antibodies (Anca) MOB
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Antisera, Fluorescent, Brucella Spp. GSM
    Enzyme Linked Immunoabsorbent Assay, Mumps Virus LJY
    General Purpose Reagent PPM
    Enzyme Linked Immunoabsorbent Assay, Rubeola Igg LJB
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    Radioimmunoassay, Pregnenolone JNG
    Radioimmunoassay, Acth CKG
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
    Radioimmunoassay, Aldosterone CJM
    Shaker/Stirrer JRQ
    Radioimmunoassay, Estriol CGI
    Autoantibodies, Endomysial(Tissue Transglutaminase) MVM
    Reagent, Coronavirus Serological QKO
    Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control DHN
    Mounting Media LEB
    Radioimmunoassay, 17-Hydroxyprogesterone JLX
    Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System NVV
    Radioimmunoassay, Prolactin (Lactogen) CFT
    Microscope, Fluorescence/U.V. IBK
    Respiratory Syncytial Virus - Elisa MCE
    Anti-Phospholipase A2 Receptor PGV
    Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 OEG
    Radioimmunoassay, Total Estrogens, Nonpregnancy JMD
    Radioimmunoassay, Angiotensin I And Renin CIB
    Antisera, Cf, Parainfluenza Virus 1-4 GQT
    Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) NBS
    Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica JQT
    Condensers, Microscope KEI
    Immunoassay, Insulin-Like Growth Factor Binding Protein-1 OAM
    Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 GNM
    Reagent, Borrelia Serological Reagent LSR
    Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis NIY
    Anti-Dna Indirect Immunofluorescent Solid Phase KTL
    Electrophoretic Separation, Alkaline Phosphatase Isoenzymes CIN
    Anti-Glutamate Receptor (Type Nmda) Ifa OSK
    Antisera, Positive Control, Echinococcus Spp. GPE
    Legionella, Spp., Elisa MJH
    Radioimmunoassay, Cortisol CGR
    Extractable Antinuclear Antibody, Antigen And Control LLL
    Anti-Ribosomal P Antibodies MQA
    Anti-Sm Antibody, Antigen And Control LKP
    Anti-Rnp Antibody, Antigen And Control LKO
    Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) NHX
    Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) JKC
    Column Chromatography & Color Development, Hydroxyproline JMM
    Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control DBM
    Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. LJZ
    Radioimmunoassay, Androstenedione CIZ
    Antigen, B. Pertussis GOX
    Antigen, Fluorescent Antibody Test, Schistosoma Mansoni GNH
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Radioimmunoassay, Progesterone JLS
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    Autoantibodies, Nuclear Body Protein, Sp100 NUM
    Autoantibodies, Nuclear Pore Glycoprotein Gp210 NRI
    Radioimmunoassay, Total Triiodothyronine CDP
    System, Test, Osteocalcin NEO
    Radioimmunoassay, Estrone CGF
    Instrumentation For Clinical Multiplex Test Systems NSU
    Reagents, Cysticercosis MDJ

    Proprietary Names

    IDS-iSYS CTX-I (Crosslaps) Control Set Anti-Influenza A Virus ELISA (IgG) IDS iSYS 1,25 Dihydroxy Vitamin D IDS iSYS 1,25 Dihydroxy Vitamin D Calibration Verifiers IDS iSYS 1,25 Dihydroxy Vitamin D Control Set Anti-dsDNA-NcX ELISA (IgG) Anti-West Nile Virus ELISA (IgG) Anti-Desmoglein 1 ELISA (IgG) Anti-Desmoglein 3 ELISA (IgG) Anti-Strongyloides ELISA (IgG) IDS-iSYS Insulin-like Growth Factor-I IGF-I Calibration Verifiers IDS-iSYS 17-OH Progesterone Control Set IDS-iSYS 17-OH Progesterone Calibration Verifiers IF Sprinter EUROBlotMaster EUROBlotMaster 44 Sprinter XL EUROLabWorkstation IFA UNIQO 160 IGF-I ELISA IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) IDS-iSYS Human Growth Hormone (hGH) Anti-Adenovirus ELISA (IgG) Anti-Gliadin (GAF-3X) ELISA (IgA) IDS-iSYS Intact PTH IDS-iSYS Intact PTH Control Set IDS-iSYS Intact PTH Calibration Verifiers EUROPLUS Granulocyte Mosaic 25 EUROPattern IFA: Granulocyte Mosaic 2 EUROPattern IFA: Granulocyte Mosaic 13 EUROPattern EUROPLUS Granulocyte Mosaic 22 EUROPattern EUROPLUS Granulocyte Mosaic 32 EUROPattern EUROPattern Classifier EUROIMMUN Analyzer I EUROIMMUN Analyzer I-2P EUROBlotOne EUROLabWorkstation ELISA System liquid concentrate Device Qualification Test Kit EUROLabWorkstation ELISA Device Qualification Test Kit EUROLabLiquidHandler IDS-iSYS System Liquid (Syst l) IDS-iSYS Trigger Set IDS-iSYS Cuvettes IDS-iSYS Wash Solution (Wash S) Device Qualification Test Kit EUROLabWorkstation IFA IDS Immunocleaner IDS-iSYS D-Sorb Solution Device Qualification Test Kit EUROIMMUN Analyzer I / I-2P IDS Top Cap Set IDS-iSYS Cartridge Check System (CCS) Anti-Brucella abortus ELISA (IgG) Anti-Mumps Virus AT ELISA (IgG) Anti-Mumps Virus ELISA (IgG) ELISA wash buffer 10x conc. FITC-labelled anti-human IgG with propidium iodide for EUROPattern EUROIMMUN Immunoblot Washbuffer Adjustment solution Secondary reagents immunoblot (IgG) Secondary reagents immunoblot (IgM) ELISA enzyme conjugate, anti-human IgA EUROArray wash buffer set ELISA sample buffer PBS (IFA) FITC-labelled anti-human IgA Sample buffer (IFA) EUROSORB (IFA) Tween 20 (IFA) ELISA Stop solution ELISA chromogen/substrate solution FITC-labelled anti-human IgG with Evans Blue FITC-labelled anti-human IgA with Evans Blue WASH REAGENT 2 Anti-Measles Virus ELISA 2 (IgG) Anti-Measles Virus ELISA (IgG) IDS-iSYS Free Testosterone EUROPLUS Granulocyte Mosaic 22 EUROPLUS Granulocyte Mosaic 32 Pregnenolone ELISA IDS ACTH II ANA Screen ELISA (IgG) 1,25-Dihydroxy Vitamin D EIA IDS-iSYS Aldosterone IDS-iSYS Aldosterone Control Set IDS-iSYS Aldosterone Calibration Verifiers Anti-Influenza B Virus ELISA (IgG) Anti-MPO ELISA (IgG) IDS-iSYS XPrep Free Estriol ELISA IFA: Oesophagus (Monkey) IgA EUROPattern IFA: Oesophagus (Monkey) IgA Anti-SARS-CoV-2 ELISA (IgG) IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers IFA 40: HEp-20-10 Anti-PR3-hn-hr ELISA (IgG) Mounting medium (IIFT) 17-OH Progesterone ELISA Total Testosterone ELISA EUROLabOffice EUROLabOffice 4 25-Hydroxy Vitamin DS EIA IDS Prolactin IDS SHBG EUROPattern Microscope Live Anti-RSV ELISA (IgG) IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Calibration Verifiers IDS-iSYS Human Growth Hormone (hGH) Calibration Verifiers IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set Anti-PLA2R IFA Anti-BP230-CF ELISA (IgG) Total Estrogens ELISA IDS-iSYS Direct Renin Control Set IDS-iSYS Direct Renin IDS-iSYS Direct Renin Calibration Verifiers IFA: Granulocyte Mosaic 13 IFA: Granulocytes (HCHO) IFA: Granulocyte Mosaic 2 IFA: Granulocytes (EOH) Anti-Parainfluenza Viruses Pool ELISA (IgG) Anti-LKM-1 ELISA (IgG) EUROLineScan EUROStar III Plus EUROPicture EUROStar IV Plus IFA 40: HEp-20-10 EUROPattern EUROPattern Microscope Anti-tissue Transglutaminase ELISA (IgA) Anti-tissue Transglutaminase ELISA (IgG) IDS-iSYS Insulin like Growth Factor-I (IGF-I) IDS SDSpeed Calc IFA Mosaic: Coxsackie virus Type A7 / Type B1 (IgG) IFA Mosaic: Coxsackie virus B Types (IgG) IFA Mosaic: Coxsackie virus A Types (IgG) IFA Mosaic: Coxsackie virus (IgG) Anti-Borrelia burgdorferi US WESTERNBLOT (IgG) Anti-SLA/LP ELISA (IgG) ANA IFA: HEp-20-10 IFA: Crithidia luciliae (anti-dsDNA) EUROPattern 25-Hydroxy Vitamin D RIA IDS Intact PTHN IDS-iSYS 25 VitDS Control Set IDS-iSYS 25 VitDS Calibrator Set IDS-iSYS 25 VitDS IDS-iSYS Ostase® BAP Anti-Glutamate receptor (type NMDA) IFA EUROLINE-WB Anti-Echinococcus (IgG) Anti-Echinococcus ELISA (IgG) Anti-Echinococcus EUROLINE WB (IgG) Anti-Legionella pneumophila ELISA (IgG) IDS Cortisol Anti-nRNP/Sm ELISA (IgG) Anti-Scl-70 ELISA (IgG) Anti-ribosomal P Proteins ELISA (IgG) Anti-Sm ELISA (IgG) Anti-Jo-1 ELISA (IgG) Anti-Centromeres ELISA (IgG) Anti-SS-B ELISA (IgG) Anti-SS-A ELISA (IgG) Anti-CCP ELISA (IgG) Dehydroepiandrosterone Sulfate (DHEA-S) ELISA Dehydroepiandrosterone (DHEA) ELISA Serum CrossLaps® (CTX-I) ELISA Urine BETA CrossLaps® (CTX-I) ELISA Alpha CrossLaps® (CTX-I) EIA IDS-iSYS CTX-I (CrossLaps®) Urine CartiLaps ® (CTX-II) EIA Urine CrossLaps® (CTX-I) EIA Anti-M2-3E ELISA (IgG) Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) Anti-West Nile Virus ELISA (IgM) IDS iSYS Multi Discipline Automated System IDS i20 IDS-i10 Anti-Mycoplasma pneumoniae ELISA (IgG) Anti-PLA2R ELISA (IgG) IDS Androstenedione Calibrator Set IDS SHBG Calibration Verifiers IDS Beta CrossLaps® (CTX-I) Calibrator Set IDS ACTH II Control Set IDS Cortisol Control Set IDS-iSYS Ostase® BAP Control Set IDS Beta CrossLaps® (CTX-I) Control Set IDS Cortisol Calibrator Set IDS Androstenedione Control Set IDS Prolactin Calibrator Set IDS-iSYS Free Testosterone Control Set IDS-iSYS Ostase® BAP Calibration Verifiers IDS SHBG Control Set IDS ACTH II Calibrator Set Androstenedione ELISA IDS Androstenedione EUROLINE ENA Profile 9 Ag (IgG) EUROLINE ENA ProfilePlus 4 (IgG) Anti-BP180-NC16A-4X ELISA (IgG) EUROLINE Bordetella pertussis (IgG) Anti-Schistosoma ELISA (IgG) Anti-Schistosoma mansoni IFA (IgG) IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern MERGITE! 10 MERGITE! 50 IDS-iSYS Diluent A IDS-iSYS Diluent C Reagent tray for incubation of slides TITERPLANE set for the incubation of slides with 50 fields IDS-iSYS Diluent B 25-OH Vitamin D ELISA 1,25-Dihydroxy Vitamin D RIA IDS-iSYS 17-OH Progesterone Ostase BAP EIA Anti-Gliadin (GAF-3X) ELISA (IgG) EURORealTime SARS-CoV-2 EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) Free Triiodothyronine (FT3) ELISA N-MID® Osteocalcin ELISA IDS-iSYS Insulin like Growth Factor–I (IGF-I) Control Set Anti-ENA Pool ELISA (IgG) Estrone ELISA Lyme ELISA (IgG/IgM) EUROArrayProcessor EUROArrayScanner EUROArrayProcessor Reagent tray set EuroArrayScan EUROArrayProcessor Pre-PCR Software Anti-Toxocara ELISA (IgG) Free Testosterone ELISA

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)