BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VALIDATE CT Calibration Verification/Linearity Test Kit, product code:907re

    Reg #: 1226774 · FEI: 3003407015 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    39
    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
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    VALIDATE CT Calibration Verification/Linearity Test Kit, product code:907re VALIDATE Fertility 4 Calibration Verification/Linearity Test Kit, product code: 305re AccuTrak T-Uptake Calibration Verification Panel, product code:2400-0259 VALIDATE tTau CSF Calibration Verification/Linearity Test Kit, product code:805re Accuplex SARS-COV-2 Full genome VALIDATE Ferritin Calibration Verification/Linearity Test Kit, product code:307 VALIDATE IL-6 Calibration Verification/Linearity Test Kit, product code:509ro VALIDATE Procalcitonin Calibration Verification/Linearity Test Kit, product code:403ab, 403ro VALIDATE HbA1c Calibration Verification/Linearity Test Kit, product code:605, 605sa, 605to VALIDATE Hepatitis B Surface IgG Antibody (aHBs) Calibration Verification/Linearity Test Kit, product code:801mm VALIDATE HS Troponin Calibration Verification/Linearity Test Kit, product code:405ab VALIDATE Whole Blood Glucose Calibration Verification/Linearity Test Kit, product code:607ro VALIDATE THY2 Hormone Calibration Verification/Linearity Test Kit, product code:908ro VALIDATE PTH Calibration Verification/Linearity Test Kit, product code:303ro VALIDATE Anti-SARS-CoV2 IgG Calibration Verification/Linearity Test Kit, product code: 510mm VALIDATE Anti-CCP (210RE) NTproBNP Install Kit C-1001RO VALIDATE ACTH Calibration Verification/Linearity Test Kit, product code:302mm VALIDATE Growth Hormone Calibration Verification/Linearity Test Kit, product code:508ro VALIDATE Toxo IgG Calibration Verification/Linearity Test Kit, product code: 803re VALIDATE® PSA Calibration Verification/Linearity Test Kit, product code: 406ab ACCURUN Anti-SARS-CoV-2 FT4 Install Kit C-1002RO AccuPlex HEV RNA control AccuTrak aTPO Calibration Verification Panel, product code: 2400-0254 AccuTrak aTSHR Calibration Verification Panel, product code: 2400-0255 AccuTrak sFlt-1 Calibration Verification Panel AccuTrak aTG Calibration Verification Panel, product code: 2400-0253 VALIDATE PTau181 Plasma Calibration Verification/Linearity Test Kit, product code:806re VALIDATE Methotrexate Calibration Verification/Linearity Test Kit, product code:310ro ACCURUN Anti-SARS-CoV-2 IgM Controls Kit VALIDATE VIT D Calibration Verification/Linearity Test Kit, product code: 506ro VALIDATE Rubella IgG Calibration Verification/Linearity Test Kit, product code: 802re VALIDATE Growth Hormone 2 Calibration Verification/Linearity Test Kit, product code: 511ro VALIDATE Folate RBC Calibration Verification/Linearity Test Kit, product code 309re VALIDATE pTau181 CSF Calibration Verification/Linearity Test Kit, product code:804re ACCURUN Cytomegalovirus (CMV) Positive Molecular Control VALIDATE OCN Calibration Verification/Linearity Test Kit, product code:305re VALIDATE B-CTx Calibration Verification/Linearity Test Kit, product code: 304re

    Establishment Types

    Manufacture Medical Device