BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HEMAGEN DIAGNOSTICS, INC.

    Reg #: 1181055 · FEI: 1181055 · Expires 2026
    View on FDA
    Products
    43
    Proprietary Names
    112
    Establishment Types
    1
    Classifications
    42

    Registration Details

    Registration Name
    HEMAGEN DIAGNOSTICS, INC.
    Registration Number
    1181055
    FEI Number
    1181055
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2900 LOCH RAVEN RD
    City
    Baltimore
    State
    MD
    ZIP
    21218
    Country
    US

    Regulatory Submissions

    510(k) Number
    K930272

    Owner / Operator

    Firm Name
    HEMAGEN DIAGNOSTICS, INC.
    Operator Number
    1221107
    Address
    2900 LOCH RAVEN RD, --
    City
    Baltimore
    State
    MD
    Postal Code
    21218
    Country
    US

    Products

    Device Name Product Code
    Antigen, Cf (Including Cf Control), Cytomegalovirus GQH
    Enzyme Linked Immunosorbent Assay, T. Cruzi MIU
    Extractable Antinuclear Antibody, Antigen And Control LLL
    System, Test, Rheumatoid Factor DHR
    Test, Donor, Cmv MZE
    System, Test, Anticardiolipin Immunological MID
    Test System, Antineutrophil Cytoplasmic Antibodies (Anca) MOB
    Calibrator, Secondary JIT
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control DBM
    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV
    Antisera, Cf, Herpesvirus Hominis 1,2 GQO
    Respiratory Syncytial Virus, Antigen, Antibody, Ifa LKT
    Analyzer, Chemistry, Centrifugal, For Clinical Use JJG
    Antinuclear Antibody, Antigen, Control LKJ
    General Purpose Reagent PPM
    Antiserum, Fluorescent, Rubeola GRE
    Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control DHN
    Colorimetric Method, Lipoproteins JHM
    Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Enzyme Immunoassay, Theophylline KLS
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
    Bromcresol Green Dye-Binding, Albumin CIX
    Enzymatic, Carbon-Dioxide KHS
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Diazo Colorimetry, Bilirubin CIG
    Antiserum, Fluorescent, Mumps Virus GRA
    Calibrators, Drug Specific DLJ
    Cresolphthalein Complexone, Calcium CIC
    Test, Time, Partial Thromboplastin GGW
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
    Antiserum, Cf, Epstein-Barr Virus GNP
    Antigen, Cf, Psittacosis (Chlamydia Group) GPW
    Calibrator, Primary JIS
    Ammonium Molybdate And Ammonium Vanadate, Phospholipids CEL
    Antigens, If, Toxoplasma Gondii GLZ
    Anti-Human Globulin, Fta-Abs Test GMS
    Antisera, Hai (Including Hai Control), Rubella GOK
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    Catalytic Methods, Amylase JFJ
    Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus LFZ
    MZB

    Proprietary Names

    Hemagen Cytomegalovirus (CMV) IgM Kit Virgo Cytomegalovirus (CMV) IgM Kit Hemagen Chagas EIA Kit Extractable Antinuclear Antibody (ENA) Screening Kit Virgo RNP/sm Kit Hemagen RNP/sm Kit HA Hemagen RNP/sm Kit Virgo RNP/sm Kit HA Extractable Antinuclear Antibody (ENA) Screening Kit, Scl-70 Kit Virgo RF Kit Hemagen RF Kit Virgo RF Kit HA Hemagen RF Kit HA CMV PK System Controls Extractable Antinuclear Antibody (ENA) Screening Kit, Sm Virgo Anti-Cardiolipin IgA Antibody Kit Hemagen Anti-Cardiolipin IgA Antibody Kit Virgo MPO (P Anca) Antibody Kit Hemagen MPO (P Anca) Antibody Kit Calibrator Standard Hemagen Analyst Multi Analyste Serum Control Anti Mitochondrial Antibody Indirect Immunofluorescent Test Kit Extractable Antinuclear Antibody (ENA) Screening Kit, SmRNP Beta 2 Glycoprotein IgM Elisa Test Kit Hemagen Herpes Simplex Virus (HSV) 1 & 2 Kit Virgo Herpes Simplex Virus (HSV) 1&2 Kit Herpes Simplex Virus (HSV) 1&2 Kit Respiratory Syncytial Virus (RSV) Test Kit Analyst Benchtop Clinical Chemistry Analyzer Hemagen ds DNA Kit HA Virgo ds DNA Kit HA Hemagen ds DNA Kit Virgo ds DNA Kit IgM universal Conjugate Virgo Respiratory Syncytial Virus(RSV) Kit Respiratory Syncytial Virus(RSV) Kit Hemagen Respiratory Syncytial Virus(RSV) Kit Measles (Rubeola) Test Kit Antinuclear Antibody, Indirect Immunofluorescent nDNA kit Beta 2 Glycoprotein IgG Elisa Test Kit Lipid Analyst Thyroxine (T4) Rotor Rheumatoid Factor Test Kit Virgo Anti-Cardiolipin Antibody IgG IgM Kit Hemagen Anti-Cardiolipin Antibody IgG IgM Kit Extractable Antinuclear Antibody (EIA) Screening Kit, Jo-1 Beta 2 Glycoprotein IgA Elisa Test Kit Hemagen ENA Jo 1 Kit HA Virgo ENA Jo 1 Kit HA Hemagen ENA Jo 1 Kit Virgo ENA Jo 1 Kit Virgo Antimitochondrial (AMA) KIt Hemagen Antimitochondrial (AMA) KIt Lipid Rotor Analyst Theophylline Rotor Analyst Physicians Office Profiler Analyst Benchtop Clinical Chemistry Analyser Panels Plus Hemagen Scl - 70 EIA Kit Virgo Scl - 70 EIA Kit Hemagen ENA Screening Kit Virgo ENA Screening Kit HA Hemagen ENA Screening Kit HA Virgo ENA Screening Kit Hemagen Mumps KIt IFA Method Virgo Mumps Kit IFA Method Analyst Theophylline Calibrator Analyst Test Rotors Cresolphthalein complexone, calcium VZV IgG IFA Virgo ANA HEp-2 Kit Hemagen ANA HEp-2 Kit ANA HEp-2 Kit Hemagen ANA HEp-2 Kit, IFA Method Virgo Epstein-Barr Virus Kit Hemagen Epstein-Barr Virus Kit Hemagen c.trach IFA Kit Virgo c.trach Kit Hemagen Chlamydia Trachomatis IFA Kit Virgo Chlamydia Trachomatis IFA Kit Analyst Analytical Rotor (T4) Thyroxine & Thyroxine Uptake Calibrator Analyst Analytical Thyroid Rotor Hemagen Toxoplasma (Toxo) Kit Virgo Toxoplasma (Toxo) Kit Extractable Antinuclear Antibody (EIA) Screening Kit, Scl-70 Extractable Antinuclear Antibody (ENA) Screening Kit, SS-A Mumps Virus Test Kit Hemagen FTA ABS IFA Kit Virgo FTA ABS IFA Kit Hemagen Rubella Kit Virgo Rubella Kit C-Reactive Protein Elisa Kit Virgo ENA Kit Hemagen ENA Kit Hemagen Analyst Analytical Test Rotor (Chem 14) Dupont Analyst Analytical Test Rotor (Chem 14) Analyst Analytical Test Rotor (Chem 14) Virgo Pr3 (C Anca) Kit Hemagen PR3 (C Anca) Kit Cytomegalovirus Elisa Kit Phosphorus Reagent Hemagen Measles (Rubeola) Kit Virgo Measles (Rubeola) Kit Hemagen SS-A/SS-B Kit HA Virgo SS-A/SS-B Kit Hemagen SS-A/SS-B Kit Virgo SS-A/SS-B Kit HA Virgo anti-neutrophil cytoplasmic antibodies (ANCA) Screen Kit Hemagen anti-neutrophil cytoplasmic antibodies (ANCA) Screen Kit Hemagen Anti-Cardiolipin IgA IgG IgM Screen Kit Virgo Anti-Cardiolipin IgA IgG IgM Screen Kit CMV PK System 2000 Test Kit Extractable Antinuclear Antibody (ENA) Screening Kit, SS-B

    Establishment Types

    Manufacture Medical Device