BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EPITOPE DIAGNOSTICS, INC.

    Reg #: 2032839 · FEI: 3004185580 · Expires 2026
    View on FDA
    Products
    77
    Proprietary Names
    164
    Establishment Types
    3
    Classifications
    77

    Registration Details

    Registration Name
    EPITOPE DIAGNOSTICS, INC.
    Registration Number
    2032839
    FEI Number
    3004185580
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    17034 Camino San Bernardo
    City
    SAN DIEGO
    State
    CA
    ZIP
    92127
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051806

    Owner / Operator

    Firm Name
    EPITOPE DIAGNOSTICS, INC.
    Operator Number
    9059077
    Address
    17034 Camino San Bernardo, --
    City
    San Diego
    State
    CA
    Postal Code
    92127
    Country
    US
    Correspondent
    PING - GAO

    Products

    Device Name Product Code
    Infliximab Test System QXT
    Cuvette, Thermostated JRI
    Lactoferrin, Antigen, Antiserum, Control DEG
    Strip, Hama Igg, Elisa, In Vitro Test System MLH
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Antigens, Cf (Including Cf Control), Adenovirus 1-33 GOD
    Free Secretory Component, Antigen, Antiserum, Control DAJ
    Zika Virus Serological Reagents QFO
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Reagents, Clostridium Difficile Toxin LLH
    Immunoassay Method, Troponin Subunit MMI
    Helicobacter Pylori LYR
    Chromogranin A QXS
    Sars-Cov-2 Serology Test QVP
    Radioimmunoassay, Acth CKG
    Reagents, Specific, Analyte MVU
    System, Test, Osteocalcin NEO
    Device, Parasite Concentration LKS
    Test, Natriuretic Peptide NBC
    Radioimmunoassay, 17-Hydroxyprogesterone JLX
    Radioimmunoassay, Gastrin CGC
    Adalimumab Assay QYD
    Radioimmunoassay, Progesterone JLS
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ
    Calprotectin, Fecal NXO
    Kit, Test,Alpha-Fetoprotein For Testicular Cancer LOJ
    Radioimmunoassay, Human Growth Hormone CFL
    Haptoglobin, Antigen, Antiserum, Control DAD
    Autoantibodies, Endomysial(Tissue Transglutaminase) MVM
    Radioimmunoassay, Total Triiodothyronine CDP
    Procalcitonin Assay PRI
    Brain Trauma Assessment Test QAT
    Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer NYI
    Radioassay, Vitamin B12 CDD
    Myeloperoxidase, Immunoassay, System, Test NTV
    Test, Epithelial Ovarian Tumor Associated Antigen (He4) OIU
    System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer NIG
    Ferritin, Antigen, Antiserum, Control DBF
    Radioimmunoassay, Immunoreactive Insulin CFP
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    System, Test, Carcinoembryonic Antigen DHX
    Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) LTK
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Atp And Creatine Kinase (Enzymatic), Creatine JLB
    Myoglobin, Antigen, Antiserum, Control DDR
    Hepatitis A Test (Antibody And Igm Antibody) LOL
    Radioimmunoassay, Parathyroid Hormone CEW
    Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples PGI
    Radioimmunoassay, Calcitonin JKR
    Radioimmunoassay, Free Thyroxine CEC
    Cytokeratin Fragments 21-1 Eia Kit OVK
    Radioimmunoassay, Total Thyroxine CDX
    System, Test, Immunological, Antigen, Tumor MOI
    Anti-Müllerian Hormone Test System PQO
    Radioimmunoassay, Estradiol CHP
    Radioimmunoassay, Glucagon JME
    Immunochemical, Thyroglobulin Autoantibody JNL
    System, Test, Her-2/Neu, Monitoring NCW
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ
    Fibrin Split Products GHH
    Reagent, Occult Blood KHE
    Cryptosporidium Spp. MHJ
    P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin JNN
    System, Test, Vitamin D MRG
    Giardia Spp. MHI
    General Purpose Reagent PPM
    System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens PUW
    Enzyme Linked Immunoabsorbent Assay, Rotavirus LIQ
    Alzheimer’S Disease Pathology Assessment Test QSE
    Acid, Folic, Radioimmunoassay CGN
    Radioimmunoassay, Luteinizing Hormone CEP
    Radioimmunoassay, C-Peptides Of Proinsulin JKD
    System, Test, Human Chorionic Gonadotropin DHA
    Antibodies, Gliadin MST
    System, Test, Thyroid Autoantibody JZO
    Radioimmunoassay, Prolactin (Lactogen) CFT

    Proprietary Names

    CL0010 EDI™Anti-Infliximab CLIA Kit CL0009 EDI™Infliximab CLIA Kit CL010 ECL25 Cuvettes CL011 ECL100 Cuvettes CL0011 EDI™ Fecal Lactoferrin CLIA Kit KT-806 Human Anti-Human Antibody (HAHA) ELISA Kit KT-805 Human Anti-Mouse Antibody (HAMA) ELISA Kit KT-807 MAHA ELISA Kit SKT-015 Human Thyroid Stimulating Hormone CLIA Kit KT-918 EpiTuub Fecal Adenovirus Antigen Rapid Test Kit KT-842 Fecal Adenovirus Antigen ELISA Kit CL0012 EDI™ Fecal Secretory IgA CLIA Kit KT 898 Serolisa™ Human Anti-Zika Virus IgM ELISA Kit KT 897 Serolisa™ Human Anti-Zika Virus IgG ELISA Kit ECL25 ECL100 QSE180 Autosampler KT-935 EpiTuub® Fecal C. difficile Antigen Test Kit KT-835 Fecal C.difficile Toxin B ELISA Kit KT-828 Fecal C. difficile GDH ELISA Kit KT-834 Fecal C.difficile Toxin A ELISA Kit KT-836 Fecal C.difficile Toxin A & B ELISA Kit CL0827 Fecal Clostridium Difficile Toxin A CLIA Kit CL0828 Fecal Clostridium Difficile Toxin B CLIA Kit CL0824 Fecal Clostridium Difficile GDH Antigen CLIA Kit CL0836 Fecal Clostridium Difficile Toxin A & B CLIA Kit SKT-071 Human cardiac troponin I CLIA Kit SKT-050 Human High-Sensitivity Cardiac Troponin T CLIA Kit KT-929 EpiTuub Fecal H. pylori Antigen Rapid Test Kit KT-1015 Helicobacter Pylori IgG ELISA Kit KT-826 Fecal Helicobacter Pylori Antigen ELISA Kit KT-113 eCasset™ Helicobacter pylori Antigen Rapid Test Kit CL0826 Fecal Helicobacter pylori Antigen CLIA Kit KT-824 Fecal H.pylori Antigen ELISA Kit KT-812 Human Chromogranin A ELISA Kit CL0820 Human Chromogranin A CLIA Kit KT-820 Human Chromogranin A ELISA Kit KT-855 Human Chromogranin A ELISA Kit KT 1034 COVID-19 Nucleocapsid IgG Quantitative ELISA Kit KT 1033 Novel Coronavirus COVID-19 IgM ELISA Kit KT 1036 Quantitative SARS-CoV-2 Neutralizing Antibody ELISA Kit KT 1032 Novel Coronavirus COVID-19 IgG ELISA Kit KT 1035 Quantitative SARS-CoV-2 Spike Protein IgG ELISA Kit KT 882 EDI™ Human ACTH ELISA Kit KT 879 EDI™ Human Intact FGF-21 ELISA Kit KT 876 EDI™ Total GLP-1 ELISA Kit KT 871 EDI™ Active GLP-1 (7-36) Specific ELISA Kit KT 878 EDI™ Rodent Active GLP-1 (7-36) Specific ELISA Kit KTR 873 Serolisa™ Human nFGF-21 ELISA Kit KTR 866 Serolisa™ Human ncFGF-21 ELISA Kit KT 800 EDI™ Human Fetuin-A ELISA Kit KT 602 EDI™ Human Total GLP-1 ELISA Kit KTR 874 Serolisa™ Human cFGF-21 ELISA Kit KT-809 Human Osteocalcin (1-43/49) Specific ELISA Kit CL0809 Human Osteocalcin (1-43/49) Specific CLIA Kit FPC300 Fecal Ova/Parasite Concentration Kit FPC200 Fecal Ova/Parasite Concentration Kit SKT-031 Human N-terminal pro brain natriuretic peptide CLIA Kit CL0817 EDI 17-OH-Progesterone CLIA Kit SKT-045 Human Gastrin-17 CLIA Kit CL0015 EDI™ Anti-Adalimumab CLIA Kit CL0014 EDI™ Adalimumab CLIA Kit SKT-022 Human Progesterone CLIA Kit SKT-016 Human Follicle-stimulating Hormone CLIA Kit KT-920 EpiTuub Calprotectin Rapid Test Kit KT-112 eCasset™ Calprotectin Rapid Test Kit KT-921 EpiTuub Calprotectin Rapid Test Kit KT-849 Quantitative Fecal Calprotectin ELISA Kit CL0849 Human Calprotectin CLIA Kit SKT-026 Human Alpha Fetoprotein CLIA Kit SKT-042 Human Growth Hormone CLIA Kit KT 819 EDI™ Human Growth Hormone ELISA Kit EDI CL0004 Tissue Transglutaminase IgG CLIA Kit CL0005 Tissue Transglutaminase IgA CLIA Kit SKT-040 Total Triiodothyronine CLIA Kit SKT-038 Free Triiodothyronine CLIA Kit SKT-025 Human Procalcitonin CLIA Kit CL0013 EDI™ Glial Fibrillary Acidic Protein CLIA kit SKT-056 Cancer Antigen 15-3 (CA15-3) CLIA Kit KT-716 EDI™ Vitamin B12 ELISA Kit SKT-070 Human Vitamin B12 CLIA Kit KT-880 Quantitative Fecal/Urine Myeloperoxidase ELISA Kit KT-890 Quantitative Serum/Plasma Myeloperoxidase ELISA Kit SKT-033 Human Epididymal protein 4 (HE4) CLIA Kit SKT-057 Cancer Antigen 19-9 (CA19-9) CLIA Kit SKT-043 Human Ferritin CLIA Kit KT 886 EDI™ Human Insulin ELISA Kit SKT-048 Human Insulin CLIA Kit KT 887 EDI™ Human Ultra Sensitive Insulin ELISA Kit SKT-020 Human Testosterone CLIA Kit SKT-029 Human Carcinoembryonic Antigen CLIA Kit SKT-035 Cancer Antigen 125 (CA-125) CLIA Kit KT-854 Fecal Sample Collection Kit KT-843 Calprotectin Sample Collection Kit KT-848 Stool Sampler Kit 31315 Stool Sampler 30210 Fecal Sample Collection Kit SKT-024 Human Creatine kinase-MB CLIA Kit SKT-051 Human Myoglobin CLIA Kit KT-868 Hepatitis A Virus IgM ELISA Kit KT-867 Direct & Quantitative HAV Antibody (IgG) ELISA Kit KT-869 Total HAV Antibody ELISA Kit KT-888 Human Intact PTH ELISA Kit KTR-1027 Herpes Simplex Virus Type I & II (HSV-1+2) IgM ELISA Kit KTR-1030 Herpes Simplex Virus Type II (HSV-2) IgG ELISA Kit KTR-1031 Herpes Simplex Virus Type II (HSV-2) IgM ELISA Kit KTR-851 VZV Antibody (IgG) Quantitative ELISA Kit KTR-1028 Herpes Simplex Virus Type I (HSV-1) IgG ELISA Kit KTR-1029 Herpes Simplex Virus Type I (HSV-1) IgM ELISA Kit KTR-1026 Herpes Simplex Virus Type I & II (HSV-1+2) IgG ELISA Kit KT-813 Human Calcitonin ELISA Kit SKT-037 Free Thyroxine CLIA Kit SKT-032 Human Cytokeratin fragment 19 (CYFRA21-1) CLIA Kit SKT-039 Total Thyroxine CLIA Kit CL0812 Human Anti-Mullerian Hormone CLIA Kit CL0804 Human Anti-Mullerian Hormone CLIA Kit KT-804 Human Anti-Mullerian Hormone ELISA Kit SKT-019 Human Estradiol CLIA Kit SKT-044 Human Anti-Thyroglobulin Antibody CLIA Kit SKT-060 Human Thyroglobulin CLIA Kit CL0815 Total Prostate- specific antigen CLIA kit CL0816 Free Prostate- specific antigen CLIA kit SKT-052 Human D-Dimer CLIA Kit KT-313 CARE™ Fecal Occult Blood (FOB) Test CL0814 Fecal Cryptosporidium parvum Antigen CLIA Kit KT-839 Fecal Cryptosporidium parvum Antigen ELISA Kit KT-928 EpiTuub Fecal Cryptosporidium parvum Antigen Rapid Test CL0006 Fecal Pancreatic Elastase-1 CLIA Kit KT-715 EDI™ Total 25-OH Vitamin D EIA Kit KT 625 Serolisa™ Total 25-OH Vitamin D EIA Kit SKT-041 Human 25-Hydroxy Vitamin D CLIA Kit KT-815 EDI™ Total 25-OH Vitamin D EIA Kit KT-845 Human Anti-Giardia lamblia IgA ELISA Kit KT-838 Fecal Giardia lamblia Antigen ELISA Kit CL0813 Fecal Giardia lamblia Antigen CLIA Kit KT-927 EpiTuub Fecal Giardia lamblia Antigen Rapid Test KT-846 Human Anti-Giardia lamblia IgG ELISA Kit KT-847 Human Anti-Giardia lamblia IgM ELISA Kit 30669 Fecal Extraction Buffer P-595-A Trigger Solution A P-595 Trigger Solution A and B P-594 Wash Reagent P-595-B Trigger Solution B CL012 Light Check Solution KT-917 EpiTuub Fecal Rotavirus Antigen Rapid Test Kit KT-841 Fecal Rotavirus ELISA Kit CL0079 Beta-amyloid (1-40) CLIA Kit CL0081 Phosphorylated-Tau 181 CLIA Kit CL0080 Total-tau CLIA Kit CL0082 Beta-amyloid (1-42) CLIA Kit SKT-073 Human Folate CLIA Kit KT 717 EDI™ Folate ELISA Kit SKT-017 Human Luteinizing Hormone CLIA Kit KT 891 Serolisa™ High Sensitive Human C-Peptide ELISA Kit KT 881 EDI™ Human C-peptide ELISA Kit SKT-023 Human C-peptide CLIA Kit SKT-021 ? Human Chorionic Gonadotropin CLIA Kit CL0008 EDI™ Deamidated Gliadin Peptide, IgG CLIA Kit CL0007 EDI™ Deamidated Gliadin Peptide, IgA CLIA Kit KT-830 Human Anti-Gliadin IgA ELISA Kit KT-831 Human Anti-Gliadin IgG ELISA Kit SKT-027 Anti-thyroid peroxidase antibody CLIA Kit SKT-018 Human Prolactin CLIA Kit

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility