BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INFINITI FACTOR II-V Assay

    Reg #: 3005406097 · FEI: 3005406097 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    AUTOGENOMICS, INCORPORATED
    Registration Number
    3005406097
    FEI Number
    3005406097
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1600 Faraday Avenue
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060564

    Owner / Operator

    Firm Name
    Prescient Medicine Holdings Inc DBA SOLVD Health
    Operator Number
    10061771
    Address
    1600 Faraday Avenue
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Heather Carbaugh

    Products

    Device Name Product Code
    Test, Factor V Leiden Mutations, Genomic Dna Pcr NPQ
    Instrumentation For Clinical Multiplex Test Systems NSU
    Test, Factor Ii G20210a Mutations, Genomic Dna Pcr NPR

    Proprietary Names

    INFINITI FACTOR II-V Assay INFINITI FACTOR II Assay INFINITI Factor V Leiden Assay

    Establishment Types

    Manufacture Medical Device