BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    Neonatal IRT FEIA

    Device
    EU IVDD · Eu Ivd General ·Labsystems Diagnostics Oy·On the market

    DELFIA Neonatal IRT kit 

    Device
    EU IVDD · Eu Ivd General ·Wallac Oy·On the market·32 countries

    GSP Neonatal IRT kit

    Device
    EU IVDD · Eu Ivd General ·Wallac Oy·On the market·32 countries

    DELFIA Neonatal IRT kit

    Device
    EU IVDD · Eu Ivd General ·Wallac Oy·On the market·32 countries

    AutoDELFIA Neonatal IRT kit

    Device
    EU IVDD · Eu Ivd General ·Wallac Oy·On the market·32 countries

    Thermidas IRT-384 Tablet

    Device
    EU MDR · Eu Md Class 2a ·TherMidas Oy·On the market·5 countries

    DELFIA NEONATAL IRT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AUTODELFIA NEONATAL IRT KIT, MODEL B005-112

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DELFIA NEONATAL IRT KIT, MODEL A005-110

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212

    FDA Enforcement
    Class III ·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·September 12, 2018

    Neonatal IRT FEIA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Labsystems Diagnostics Oy·1 device

    Thermidas IRT-384 Tablet

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·TherMidas Oy·1 device

    DELFIA Neonatal IRT kit 

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Wallac Oy·1 device

    GSP Neonatal IRT kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Wallac Oy·1 device

    DELFIA Neonatal IRT kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Wallac Oy·1 device

    AutoDELFIA Neonatal IRT kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Wallac Oy·1 device

    SARS-CoV-2 RT-qPCR Reagent kit

    Device
    EU IVDD · Eu Ivd General ·Wallac Oy·On the market·32 countries

    PKamp Respiratory SARS-CoV-2 RT-PCR Panel kit

    Device
    EU IVDD · Eu Ivd General ·Wallac Oy·No longer on the market·32 countries

    PKamp Respiratory SARS-CoV-2 RT-PCR Panel kit

    Device
    EU IVDD · Eu Ivd General ·Wallac Oy·On the market·32 countries