BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TRUE DIAGNOSTICS, INC.

    Reg #: 3027500452 · FEI: 3027500452 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    5

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    Registration Details

    Registration Name
    TRUE DIAGNOSTICS, INC.
    Registration Number
    3027500452
    FEI Number
    3027500452
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5919 Farnsworth Ct
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172257

    Owner / Operator

    Firm Name
    True Diagnostics, Inc.
    Operator Number
    10058307
    Address
    2782 Loker Ave West
    City
    Carlsbad
    State
    CA
    Postal Code
    92010
    Country
    US
    Correspondent
    Jerry Lee

    Products

    Device Name Product Code
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Coronavirus Antigen Detection Test System. QKP
    Syringe, Piston FMF
    Visual, Pregnancy Hcg, Prescription Use JHI
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX

    Proprietary Names

    CVS Health Digital Ovulation Test VeriClear

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility