BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Invivoscribe, Inc.

    Reg #: 3014173060 · FEI: 3014173060 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Invivoscribe, Inc.
    Registration Number
    3014173060
    FEI Number
    3014173060
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10222 Barnes Canyon Road, Building 1
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    PMA Number
    P160040

    Owner / Operator

    Firm Name
    Invivoscribe, Inc.
    Operator Number
    10023809
    Address
    10222 Barnes Canyon Rd., Bldg 1
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US

    Products

    Device Name Product Code
    General Purpose Reagent PPM
    Somatic Gene Mutation Detection System OWD
    Reagents, Specific, Analyte MVU

    Proprietary Names

    Invivoscribe Branded RNA and DNA for Oncology Test Development LeukoStrat CDx FLT3 Mutation Assay

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device