BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BION ENTERPRISES, LTD.

    Reg #: 1419968 · FEI: 1419968 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    37
    Establishment Types
    3
    Classifications
    22

    Registration Details

    Registration Name
    BION ENTERPRISES, LTD.
    Registration Number
    1419968
    FEI Number
    1419968
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    455 State St Ste 100
    City
    DES PLAINES
    State
    IL
    ZIP
    60016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K894623

    Owner / Operator

    Firm Name
    BION ENTERPRISES, LTD.
    Operator Number
    1419968
    Address
    455 STATE STREET,, SUITE 100
    City
    Des Plaines
    State
    IL
    Postal Code
    60016
    Country
    US
    Correspondent
    NADINE M SHABAT

    Products

    Device Name Product Code
    Respiratory Syncytial Virus, Antigen, Antibody, Ifa LKT
    Dna-Reagents, Mycoplasma Spp. LQG
    Antisera, Fluorescent, Chlamydia Spp. LKI
    General Purpose Reagent PPM
    Antisera, Cf, Herpesvirus Hominis 1,2 GQO
    Antiserum, Fluorescent, Mumps Virus GRA
    Reagent, Borrelia Serological Reagent LSR
    Antiserum, Fluorescent, Rubeola GRE
    Quality Control Slides LJG
    Antiserum, Fluorescent, Epstein-Barr Virus JRY
    Antisera, Neutralization, Echovirus 1-34 GNI
    Antigen, Cf (Including Cf Control), Cytomegalovirus GQH
    Antisera, Fluorescent, Adenovirus 1-33 GNY
    Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control DHN
    Antigen, Cf, (Including Cf Control), Varicella-Zoster GQW
    Antibody Igm, If, Epstein-Barr Virus LJN
    Antiserum, Hai, Rubeola GRG
    Mounting Media LEB
    Ph Buffer JCC
    Test, Antigen, Nuclear, Epstein-Barr Virus LLM
    Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6 GNN
    Antisera, Hai, Influenza Virus A, B, C GNS

    Proprietary Names

    Substrate Slide BION Respiratory Syncytia IFA BION MYCOPLASMA PNEUMONIA BION Chlamydia IFA Substrate Slides BION IFA DILUENT Antibody Test Systems BION Herpes Simplex Type 1 or BION Herpes Simplex Type 2 MUMPS-G IFA TEST SYSTEM Antigen Substrate Slide BION Borrelia burgdorferi MEASLES-G IFA TEST SYSTEM Control Slides BION Direct Identification VIRAL DIRECT IDENTIFICATION CELL CULTURE SUBSTRATE INFECT BION DIRECT IDENTIFI CELL CULTURE SUBSTRATE FOR EPS VIRAL DIRECT IDENTIFICATION CO BORRELIA BURGDORFERI SU EBV IgG (VCA) Test System BION ECHOVIRUS ANTI BION Cytomegalovirus, IgG Test System ADENOVIRUS IFA SLIDES BION Antinuclear Antibody (ANA) BION Varicella-Zoster IFA Substrate Slides BION Mumps Virus IFA BION EBV IgM (VCA) Test System MEASLES-M IFA TEST SYSTEM BION IFA MOUNTING MEDIA BION PBS IFA BUFFER BION EBV Nuclear Antigen IFA BION COXSACKIEVIRUS A B ANTIGEN SUBSTRATE SLIDES INFLUENZA A OR B IFA SLIDES

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Repack or Relabel Medical Device