BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DLJ / Calibrators, drug specific ORH / Lamotrigine assay LAS / Drug specific control materials

    Reg #: 3015550354 · FEI: 3015550354 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    MONOCENT INC.
    Registration Number
    3015550354
    FEI Number
    3015550354
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8920 Quartz Ave
    City
    Northridge
    State
    CA
    ZIP
    91324
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101305

    Owner / Operator

    Firm Name
    Monocent Inc.
    Operator Number
    10060554
    Address
    8920 Quartz Ave
    City
    Northridge
    State
    CA
    Postal Code
    91324
    Country
    US
    Correspondent
    Shervin Taheri

    Products

    Device Name Product Code
    Lamotrigine Assay ORH
    Calibrators, Drug Specific DLJ
    Drug Specific Control Materials LAS

    Proprietary Names

    DLJ / Calibrators, drug specific ORH / Lamotrigine assay LAS / Drug specific control materials

    Establishment Types

    Manufacture Medical Device