BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Multichem ID HAV IgM Positive Control

    Reg #: 1226774 · FEI: 3003407015 · 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
    1226774
    FEI Number
    3003407015
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    221 US Route 1
    City
    Cumberland Foreside
    State
    ME
    ZIP
    04110
    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

    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