BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Autosomal recessive carrier screening gene mutation detection system

    Reg #: 3007699459 · FEI: 3007699459 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    23ANDME, INC.
    Registration Number
    3007699459
    FEI Number
    3007699459
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    223 N Mathilda Ave
    City
    Sunnyvale
    State
    CA
    ZIP
    94086
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN140044

    Owner / Operator

    Firm Name
    23andMe, Inc.
    Operator Number
    10029404
    Address
    223 N. Mathilda Ave.
    City
    Sunnyvale
    State
    CA
    Postal Code
    94086
    Country
    US
    Correspondent
    Mark Pisaro

    Products

    Device Name Product Code
    Autosomal Recessive Carrier Screening Gene Mutation Detection System PKB

    Proprietary Names

    Autosomal recessive carrier screening gene mutation detection system

    Establishment Types

    Manufacture Medical Device