BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Multichem ID HAV IgM Positive Control

    Reg #: 3003610890 · FEI: 3003610890 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    31
    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
    Multi-Analyte Controls Unassayed OHQ

    Proprietary Names

    Multichem ID HAV IgM Positive Control ACCURUN 6 Multi Marker Positive Control Validate Fertility 2 unassayed calibration verification/linearity test kit Product Code 504re ACCURUN® 121 HAV IgM Positive Control Validate HbA1c unassayed calibration verification/linearity test kit, Product Code 605 Validate SP2 unassayed calibration verification/linearity test kit, Product code 602re Validate SP2 unassayed calibration verification/linearity test kit, Product code 602bc Validate Tumor Markers unassayed calibration verification/linearity test kit, Product code 407sa ACCURUN TV/MG Positive Molecular Control Kit Validate Fertility 1 unassayed calibration verification/linearity test kit Product Code 502re ACCURUN® 132 Lyme IgM Positive Control Accurun Babesia Molecular Positive Control Kit Multichem ID MM HEP1 Pos 4 x 5mL Validate Tumor Markers unassayed calibration verification/linearity test kit, Product code 407 Validate whole blood glucose unassayed calibration verification/linearity test kit, product code 607 Validate Heparin se calibration verification /linearity kit, product code 903se Validate Ferritin unassayed calibration verification/linearity test solution, Product code 307 Multichem ID MM Neg 4 x 5mL AccuPlex SARS-CoV-2, Flu A/B, and RSV Molecular Controls Kit (0505-0260) ACCURUN 4 Multi-Marker Positive Control ACCURUN 810 S2700 ACCURUN MRSA/MSSA Positive Molecular Control Multichem ID Hepatitis 2 Positive Control ACCURUN 2 Series 5600 ACCURUN 3 Multi Marker Positive Control ACCURUN 5 Multi Marker Positive Control ACCURUN® 130 Lyme IgG Positive Control Validate SP2 unassayed calibration verification/linearity test solution, Product code 602 MCID Multi-Marker Negative Control ACCURUN® 120 HAV IgG Positive Control ACCURUN 51 S2700

    Establishment Types

    Manufacture Medical Device