BEUDAMED
    2 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii ×

    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

    IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.

    FDA Enforcement
    Class III ·Terminated·Iris Diagnostics·August 8, 2012