BEUDAMED
    EU Manufacturer 🇺🇸 United States Active

    LGC Clinical Diagnostics, Inc.

    SRN: US-MF-000029697 · 221 US Route 1, 04110 Cumberland Foreside , United States
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    Basic UDI-DIs
    133
    Total Devices
    133
    On Market
    133
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    0

    Basic Information

    Address
    221 US Route 1, 04110 Cumberland Foreside , United States
    Email
    [email protected]
    Phone
    +1 207 892 1300

    Regulatory Overview

    Regulation
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    Eu Ivdd 133
    Classification
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    Eu Ivd General 133
    Device Types
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    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) 3822623 Oct 02, 2024

    Device Portfolio

    Name
    Control Kit - GC1ab L5
    Control Kit - GC3ab L5-L6
    Control Kit - PHOS L1
    VALIDATE® ACTH Test Set
    VALIDATE® ANEMIA Test Set
    VALIDATE® ANEMIA Test Set
    VALIDATE® ANEMIA Test Set
    VALIDATE® ANEMIA Test Set
    VALIDATE® Anti-SARS-CoV2 IgG Test Set
    VALIDATE® BODY FLUIDS 2 Test Set
    VALIDATE® BODY FLUIDS 3 Test Set
    VALIDATE® BODY FLUIDS Test Set
    VALIDATE® BODY FLUIDS Test Set
    VALIDATE® CHEM 17 Test Set
    VALIDATE® CHEM 4 Test Set
    VALIDATE® CM1 Test Set
    VALIDATE® CM1 Test Set
    VALIDATE® CM1 Test Set
    VALIDATE® CM1 Test Set
    VALIDATE® CM2 Test Set
    VALIDATE® CM2 Test Set
    VALIDATE® CM2 Test Set
    VALIDATE® CM3 Test Set
    VALIDATE® D-DIMER Test Set
    VALIDATE® D-DIMER Test Set
    VALIDATE® D-DIMER Test Set
    VALIDATE® FERRITIN Test Set
    VALIDATE® FERTILITY 1 Test Se
    VALIDATE® FERTILITY 1 Test Set
    VALIDATE® FERTILITY 2 Test Set
    VALIDATE® FERTILITY 2 Test Set
    VALIDATE® FERTILITY 3 Test Set
    VALIDATE® FIBRINOGEN Test Set
    VALIDATE® FIBRINOGEN Test Set
    VALIDATE® FIBRINOGEN Test Set
    VALIDATE® GC1 Test Set
    VALIDATE® GC1 Test Set
    VALIDATE® GC1 Test Set
    VALIDATE® GC1 Test Set
    VALIDATE® GC1 Test Set
    VALIDATE® GC1 Test Set
    VALIDATE® GC1 Test Set
    VALIDATE® GC1 Test Set
    VALIDATE® GC2 Test Set
    VALIDATE® GC2 Test Set
    VALIDATE® GC2 Test Set
    VALIDATE® GC2 Test Set
    VALIDATE® GC2 Test Set
    VALIDATE® GC2 Test Set
    VALIDATE® GC2 Test Set
    View all 133 devices →