BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACCURUN 52 Multi-Marker Hepatitis Positive Control 2

    Reg #: 3003610890 · FEI: 3003610890 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    35
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LGC Clinical Diagnostics, Inc.
    Registration Number
    3003610890
    FEI Number
    3003610890
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    910 Clopper road
    City
    Gaithersburg
    State
    MD
    ZIP
    20878
    Country
    US

    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
    Whole Blood Plasma, Antigen, Antiserum, Control DGQ

    Proprietary Names

    ACCURUN 52 Multi-Marker Hepatitis Positive Control 2 ACCURUN 810 Series 2700 Multi Marker Negative Control ACCURUN 25 Torch IgG Positive Control Series 1000 ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 2000 ACCURUN 26 ToRC IgM Positive Control Series 5000 MultiChem ID TORC IgM Positive Control ACCURUN 52 Multi-Marker Hepatitis Positive Control 2 S3000 ACCURUN 25 ToRCH IgG Positive Control S5000 MultiChem ID Rubella IgM Positive Control MultiChem ID ToRCH Negative Control MultiChem ID TORCH IgG Positive Control AccuPlex rEbola GP/NP Reference Material (0505-0001) ACCURUN 141 Rubella IgM Positive Control ACCURUN 31 EBV IgM Positive Control ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 700 ACCURUN 841 CT/NG Negative Control ACCURUN 127 Anti-Hepatitis Delta Positive Control ACCURUN 190 Chagas Positive Control ACCURUN 501 C. difficile Control ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100 ACCURUN 30 EBV IgG Positive Control ACCURUN 156 Reagin (Syphilis) Positive Control ACCURUN 113 HBc IgM Positive Control ACCURUN 372 HPV DNA Positive Control Series 400 ACCURUN 115 Hepatitis B Core IgG Positive Control ACCURUN 381 HPV Type 16 and 18 mRNA Positive Control Multichem ID Multi-Marker Negative Control ACCURUN 872 HPV DNA Negative Control ACCURUN 378 HPV DNA Positive Control Series 5000 ACCURUN 372 HPV DNA Positive Control Series 600 ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000 ACCURUN 810 Multi-Marker Negative Control ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 ACCURUN 136 Toxoplasma IgM Positive Control ACCURUN 125 Anti-HBs Positive Control

    Establishment Types

    Manufacture Medical Device