BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AUTOGENOMICS, INCORPORATED

    Reg #: 3005406097 · FEI: 3005406097 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    10

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    Registration Details

    Registration Name
    AUTOGENOMICS, INCORPORATED
    Registration Number
    3005406097
    FEI Number
    3005406097
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1600 Faraday Avenue
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K073014
    PMA Number
    P230032

    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
    Drug Metabolizing Enzyme Genotyping Systems NTI
    Instrumentation For Clinical Multiplex Test Systems NSU
    Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr OMM
    Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System ODW
    Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System ODV
    Kit, Dna Detection, Human Papillomavirus MAQ
    Test, Factor V Leiden Mutations, Genomic Dna Pcr NPQ
    Test, Factor Ii G20210a Mutations, Genomic Dna Pcr NPR
    Dna Specimen Collection, Saliva OYJ
    Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit QZH

    Proprietary Names

    INFINITI CYP2C19+ Assay INFINITI CYP4502D6BC Assay INFINITI UGT1A1 Assay INFINITI High Throughput System INFINITI PLUS Analyzer INFINITI MTHFR Assay INFINITI Warfarin Assay INFINITI CYP450 2C9-VKORC1 Assay INFINITI CYP2C19 Assay INFINITI FACTOR II-V Assay INFINITI FACTOR II Assay INFINITI Factor V Leiden Assay INFINITI Factor II-V & MTHFR Assay INFINITI Buccal Sample Collection Kit AvertD and AvertD Buccal Sample Collection Kit

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device