BEUDAMED
    FDA Registration Active 🇺🇸 United States

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

    Reg #: 3007088335 · FEI: 1220394 · 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
    3007088335
    FEI Number
    1220394
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    37 Birch St
    City
    Milford
    State
    MA
    ZIP
    01757
    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
    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