BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MORE DIAGNOSTICS INC.

    Reg #: 2085085 · FEI: 1000142648 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    MORE DIAGNOSTICS INC.
    Registration Number
    2085085
    FEI Number
    1000142648
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2020 11TH ST
    City
    Los Osos
    State
    CA
    ZIP
    93402
    Country
    US

    Regulatory Submissions

    510(k) Number
    K072257

    Owner / Operator

    Firm Name
    MORE DIAGNOSTICS INC.
    Operator Number
    9009779
    Address
    2020 11TH ST., --
    City
    Los Osos
    State
    CA
    Postal Code
    93402
    Country
    US
    Correspondent
    Mary Powers

    Products

    Device Name Product Code
    Drug Specific Control Materials LAS
    Enzyme Controls (Assayed And Unassayed) JJT
    Multi-Analyte Controls, All Kinds (Assayed) JJY

    Proprietary Names

    MPA CONTROLS TAC/CSA CONTROLS RAP/TAC/CSA CONTROLS hsTnI Serum Control Clinical Cardiac Control Ev/Tac/CsA Control Ev/Rap/Tac/CsA Rap/Tac/CsA Control Cyclosporine C2 Control CARDIAC MARKERS CONTROLS

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)