BEUDAMED
    Eu Ivdd Eu Ivd General On The Market 🇺🇸 United States

    Control Kit - GC1ab L5

    LGC Clinical Diagnostics, Inc. · 🇺🇸 United States
    View on EUDAMED
    Devices (same UDI-DI)
    1
    Certificates
    1
    Countries
    0
    Notified Bodies
    1

    Basic Information

    Primary DI
    00850011135419
    Basic UDI-DI Code
    B-00850011135419
    Reference
    92-001001-00
    Device Types
    Single use Sterilization
    Regulation
    Eu Ivdd
    Classification
    Eu Ivd General
    Status
    On The Market
    Manufacturer
    LGC Clinical Diagnostics, Inc.

    Additional Description

    This product is intended for use as an unassayed internal quality control to monitor the precision of laboratory testing procedures for the following analytes: albumin (ALB), blood urea nitrogen (BUN), calcium (CA), chloride (CL), cholesterol (CHOL), creatinine (CREAT), glucose (GLU), lactate (LAC), lithium (LITH), magnesium (MG), phosphorus (PHOS), potassium (K), sodium (NA), total protein (TP) and triglyceride (TRIG).

    CND Nomenclature Codes

    Code Description
    W0101050101 ASSAYED MULTICOMPONENT CONTROLS (CC)
    W0101050102 UNASSAYED MULTICOMPONENT CONTROLS (CC)

    Certificates

    Type Number
    IVDD Annex IV (excluding sections 4, 6) 3822623

    Similar Devices

    Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).

    BluBox

    Device
    EU IVDD · Eu Ivd General ·Blusense Diagnostics ApS·On the market·5 countries

    extendSURE™ HbA1c Liquid Controls

    Device
    EU IVDD · Eu Ivd General ·Canterbury Scientific Limited·On the market·19 countries

    ViroTrack Sero COVID-19 Total Ab

    Device
    EU IVDD · Eu Ivd General ·Blusense Diagnostics ApS·On the market·5 countries

    extendSURETM Haemoglobin F and A2 Calibrators

    Device
    EU IVDD · Eu Ivd General ·Canterbury Scientific Limited·On the market·8 countries

    extendSURE™ Haemoglobin F and A2 Controls

    Device
    EU IVDD · Eu Ivd General ·Canterbury Scientific Limited·On the market·8 countries

    extendSURE™ HbA1c Liquid Controls

    Device
    EU IVDD · Eu Ivd General ·Canterbury Scientific Limited·On the market·19 countries
    View all