BEUDAMED
    506 results · 61ms · Sources: EU EUDAMED, US FDA

    GSP Neonatal IRT kit

    FDA UDI
    Wallac Oy·06438147320523·For the quantitative determination of immunorea...

    Genetic Screening Processor

    FDA UDI
    Wallac Oy·06438147311040·The GSP® instrument is a fully automated, high ...

    AutoDELFIA Automatic Immunoassay System

    FDA UDI
    Wallac Oy·06438147335022·The AutoDELFIA® system (Sample Processor and Pl...

    RESOLVE Systems Hemoglobin Kit

    FDA UDI
    Wallac Oy·06438147000784·For detection of normal and variant hemoglobins.

    Eonis SCID-SMA kit

    FDA UDI
    Wallac Oy·06438147377756·The Eonis SCID-SMA kit is a device intended for...

    AutoDELFIA Neonatal Thyroxine (T4) kit

    FDA UDI
    Wallac Oy·06438147179602·Time-resolved fluoroimmunoassay for the quantit...

    AutoDELFIA Neonatal 17α-OH-progesterone kit

    FDA UDI
    Wallac Oy·06438147292486·For the quantitative determination of 17α-OH-pr...

    AutoDELFIA Inhibin A kit Level Calibrators

    FDA UDI
    Wallac Oy·06438147344406·Time-resolved fluoroimmunoassay for the quantit...

    NeoBase 2 Non-derivatized MSMS kit

    FDA UDI
    Wallac Oy·06438147356812·NeoBase™ 2 Non-derivatized MSMS kit is intended...

    GSP Neonatal Total Galactose kit

    FDA UDI
    Wallac Oy·06438147367917·For the quantitative determination of total gal...

    Screening Center

    FDA UDI
    Wallac Oy·06438147320905·Specimen Gate® Screening Center™ is intended to...

    RESOLVE Systems Neonatal Hemoglobin Kit

    FDA UDI
    Wallac Oy·06438147000814·For detection of normal and variant hemoglobins.

    VICTOR2 D

    FDA UDI
    Wallac Oy·06438147121373·VICTOR2 D will primarly be used for measuring t...

    RESOLVE Systems Hb Elution Solution

    FDA UDI
    Wallac Oy·06438147246137·For in vitro use with the RESOLVE Hemoglobin Ki...

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·AUTODELFIA HAFP KIT

    DELFIA NEONATAL 17A-OH-PROGESTERONE KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DELFIA NEONATAL THYROXINE KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DELFIA TESTTOSTERONE KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry