BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150

    Reg #: 3007088335 · FEI: 1220394 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LGC Clinical Diagnostics, Inc.
    Registration Number
    3007088335
    FEI Number
    1220394
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    37 Birch St
    City
    Milford
    State
    MA
    ZIP
    01757
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK040064

    Owner / Operator

    Firm Name
    LGC Clinical Diagnostics, Inc.
    Operator Number
    9041170
    Address
    37 Birch Street, --
    City
    Milford
    State
    MA
    Postal Code
    01757
    Country
    US
    Correspondent
    RAY - BANDZIULIS

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 ACCURUN 325 HBV DNA Positive Control Series 370 ACCURUN 325 HBV DNA Positive Control Series 200 ACCURUN 325 HBV DNA Positive Control Series 700

    Establishment Types

    Manufacture Medical Device