BEUDAMED
    FDA Registration Active 🇺🇸 United States

    bcr/abl1 Monitoring Test

    Reg #: 1550222 · FEI: 1550222 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    VWR CHEMICALS, LLC
    Registration Number
    1550222
    FEI Number
    1550222
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    28600 Fountain Pkwy
    City
    Solon
    State
    OH
    ZIP
    44139
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190076

    Owner / Operator

    Firm Name
    VWR INTERNATIONAL, LLC
    Operator Number
    9009749
    Address
    100 Matsonford Road, Building One, Suite 200
    City
    Radnor
    State
    PA
    Postal Code
    19087
    Country
    US
    Correspondent
    Aubrey Buenger

    Products

    Device Name Product Code
    Real Time Nucleic Acid Amplification System OOI
    Bcr/Abl1 Monitoring Test OYX

    Proprietary Names

    bcr/abl1 Monitoring Test

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)