BEUDAMED
    FDA Registration Active 🇺🇸 United States

    23andMe Genomics LLC

    Reg #: 3007699459 · FEI: 3007699459 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    5

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    Registration Details

    Registration Name
    23andMe Genomics LLC
    Registration Number
    3007699459
    FEI Number
    3007699459
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2555 Park Blvd
    City
    Palo Alto
    State
    CA
    ZIP
    94306
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN170046

    Owner / Operator

    Firm Name
    23andMe Genomics LLC
    Operator Number
    10029404
    Address
    2555 Park Boulevard
    City
    Palo Alto
    State
    CA
    Postal Code
    94306
    Country
    US
    Correspondent
    Mark Pisaro

    Products

    Device Name Product Code
    Cancer Predisposition Risk Assessment System QAZ
    Direct-To-Consumer Access Pharmacogenetic Assessment System QDJ
    Dna Specimen Collection, Saliva OYJ
    Autosomal Recessive Carrier Screening Gene Mutation Detection System PKB
    Genetic Variant Detection And Health Risk Assessment System PTA

    Proprietary Names

    Cancer predisposition risk assessment system 23andMe Pharmacogenetics Reports DNA specimen collection, saliva 23andMe BRCA1/BRCA2 (Selected Variants) Report 23andMe Personal Genome Service Pharmacogenetics Reports Autosomal recessive carrier screening gene mutation detection system Genetic variant detection and health risk assessment system 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) Direct-to-consumer access pharmacogenetic assessment system

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility