BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PreciseType HEA BeadCheck Kit

    Reg #: 3005967741 · FEI: 3005967741 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOARRAY SOLUTIONS LIMITED
    Registration Number
    3005967741
    FEI Number
    3005967741
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    35 Technology Dr Ste 100
    City
    Warren
    State
    NJ
    ZIP
    07059
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK130050

    Owner / Operator

    Firm Name
    BioArray Solutions Limited
    Operator Number
    10041491
    Address
    35 Technology Drive, Suite 100
    City
    Warren
    State
    NJ
    Postal Code
    07059
    Country
    US
    Correspondent
    Jesdeep Sidhu

    Products

    Device Name Product Code
    Quality Control For Molecular Immunohematology Tests PFK

    Proprietary Names

    PreciseType HEA BeadCheck Kit

    Establishment Types

    Manufacture Medical Device