BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CALBIOTECH, INC.

    Reg #: 2090110 · FEI: 3002346973 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    18
    Establishment Types
    4
    Classifications
    21

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    Registration Details

    Registration Name
    CALBIOTECH, INC.
    Registration Number
    2090110
    FEI Number
    3002346973
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1935 Cordell Ct
    City
    El Cajon
    State
    CA
    ZIP
    92020
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122809

    Owner / Operator

    Firm Name
    Calbiotech, Inc.
    Operator Number
    9046880
    Address
    1935 Cordell Court, --
    City
    El Cajon
    State
    CA
    Postal Code
    92020
    Country
    US
    Correspondent
    DAVID - BARKA

    Products

    Device Name Product Code
    Reagents, Specific, Analyte MVU
    Enzyme Linked Immunoabsorbent Assay, Rubeola Igg LJB
    Epstein-Barr Virus, Other LSE
    Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific LGC
    Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii LGD
    System, Test, Thyroid Autoantibody JZO
    Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus LFZ
    Extractable Antinuclear Antibody, Antigen And Control LLL
    Enzyme Linked Immunoabsorbent Assay, Mumps Virus LJY
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Phencyclidine LCM
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Barbiturate DIS
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Propoxyphene JXN
    Enzyme Immunoassay, Amphetamine DKZ
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    General Purpose Reagent PPM

    Proprietary Names

    Calbiotech SAR Various 14-3-3 eta; FLAER Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit Gold Standard Diagnostics Is-Anti-TG IgG ELISA Test Kit Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit Gold Standard Diagnostics Is-anti-Sm ELISA Test Kit Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test Kit Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit Sumer Urine Drug Test Cup REAGENT GENERAL PURPOSE Gold Standard Diagnostics Is-anti-Jo-1 ELISA Test Kit Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit Gold Standard Diagnostics Is-Anti-TPO IgG ELISA Test Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Manufacture Device in the United States for Export Only Repack or Relabel Medical Device