BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZEUS SCIENTIFIC LLC

    Reg #: 2242436 · FEI: 2242436 · Expires 2026
    View on FDA
    Products
    59
    Proprietary Names
    32
    Establishment Types
    4
    Classifications
    59

    Registration Details

    Registration Name
    ZEUS SCIENTIFIC LLC
    Registration Number
    2242436
    FEI Number
    2242436
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    200 EVANS WAY
    City
    BRANCHBURG
    State
    NJ
    ZIP
    08876
    Country
    US

    Regulatory Submissions

    510(k) Number
    K882440
    PMA Number
    P150042

    Owner / Operator

    Firm Name
    ZEUS SCIENTIFIC LLC
    Operator Number
    2242436
    Address
    200 EVANS WAY, --
    City
    Branchburg
    State
    NJ
    Postal Code
    08876
    Country
    US

    Products

    Device Name Product Code
    Test, Antigen, Nuclear, Epstein-Barr Virus LLM
    Thyroglobulin, Antigen, Antiserum, Control DDC
    Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control DBL
    Enzyme Linked Immunoabsorption Assay, Treponema Pallidum LIP
    General Purpose Reagent PPM
    Helicobacter Pylori LYR
    Reagents, Antibody, Legionella, Direct & Indirect Fluorescent LHL
    Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control DBE
    Antinuclear Antibody, Antigen, Control LKJ
    Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control DHN
    Autoantibodies, Endomysial(Tissue Transglutaminase) MVM
    Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control DBM
    Antigen, Cf (Including Cf Control), Cytomegalovirus GQH
    Column Chromatography & Color Development, Hydroxyproline JMM
    Test System, Antineutrophil Cytoplasmic Antibodies (Anca) MOB
    Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific LGC
    System, Test, Thyroid Autoantibody JZO
    Epstein-Barr Virus, Other LSE
    System, Test, Systemic Lupus Erythematosus DHC
    Reagent, Borrelia Serological Reagent LSR
    Antigen, Cf, (Including Cf Control), Varicella-Zoster GQW
    Enzyme Linked Immunoabsorbent Assay, Rubella LFX
    Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii LGD
    Antigens, Nontreponemal, All GMQ
    Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus LFZ
    Antisera, Fluorescent, Herpesvirus Hominis 1,2 GQL
    System, Test, Anticardiolipin Immunological MID
    Antisera, Cf, Equine Encephalitis Virus, Eee, Wee GQC
    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm MYM
    Antisera, Control For Nontreponemal Tests GMP
    Antibodies, Gliadin MST
    Anti-Human Globulin, Fta-Abs Test GMS
    Antigen, Ebv, Capsid MCD
    Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) MVJ
    Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use PIV
    Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 MXJ
    Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 MYF
    Antiserum, Fluorescent, Epstein-Barr Virus JRY
    Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster LFY
    Enzyme Linked Immunoabsorbent Assay, Mumps Virus LJY
    System, Test, Rheumatoid Factor DHR
    Antibody Igm,If, Cytomegalovirus Virus LKQ
    Reagent, Rickettsia Serological LSQ
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
    Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 OPM
    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg MYL
    Fixative, Alcohol Containing LDZ
    Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control DBJ
    Antigens, If, Toxoplasma Gondii GLZ
    Enzyme Linked Immunoabsorbent Assay, Rubeola Igg LJB
    Antisera, Fluorescent, Chlamydia Spp. LKI
    Chamber, Slide Culture KIY
    Antibody Igm, If, Epstein-Barr Virus LJN
    Reagent, Coronavirus Serological QKO
    Complement C1q, Antigen, Antiserum, Control DAK
    Anti-Dna Indirect Immunofluorescent Solid Phase KTL
    Igg, Antigen, Antiserum, Control DEW
    Extractable Antinuclear Antibody, Antigen And Control LLL
    Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. LJZ

    Proprietary Names

    MULTIPLE AUTOANTIBODIES, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL General purpose reagent ANTISMOOTH MUSCLE ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL Autoantibodies, endomysial(tissue transglutaminase) REAGENTS, ANTIBODY, LEGIONELLA, DIRECT & INDIRECT FLUORESCENT TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA) ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL SYSTEM, TEST, SYSTEMIC LUPUS ERYTHEMATOSUS ANTIGENS, NONTREPONEMAL, ALL ANTISERA, CF, EQUINE ENCEPHALITIS VIRUS, EEE, WEE ANTISERA, CONTROL FOR NONTREPONEMAL TESTS ANTIGEN, CF (INCLUDING CF CONTROL), CYTOMEGALOVIRUS SYSTEM, TEST, THYROID AUTOANTIBODY Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) ANTISERUM, FLUORESCENT, EPSTEIN-BARR VIRUS AtheNA Multi-Lyte® RF IgM Plus Test System ZEUS IFA™ ANA HEp-2 Test System ZEUS dIFine® Digital Scanner and Software REAGENT, RICKETTSIA SEROLOGICAL Antisera, fluorescent, herpesvirus hominis 1,2 AtheNA Multi-Lyte® MMRV IgG Plus Test System ANTIPARIETAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL Rat Kidney/Stomach Tissue Rat Kidney/Stomach/Liver Tissue Mouse Kidney/Stomach/Liver Tissue Devices, measure, antibodies to glomerular basement membrane (gbm) ANTISERA, FLUORESCENT, CHLAMYDIA SPP. ANA HEp-2 ASA (Monkey Esophagus) EPSTEIN-BARR VIRUS, OTHER ANTI-DNA INDIRECT IMMUNOFLUORESCENT SOLID PHASE

    Establishment Types

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