BEUDAMED
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    GenePOC™ Strep A

    FDA UDI
    GenePoc Inc·00628055344087·The GenePOC Strep A assay, performed on the rev...

    revogene™

    FDA UDI
    GenePoc Inc·00628055344001·The revogene™ instrument is intended for in vit...

    GenePOC™ CDiff

    FDA UDI
    GenePoc Inc·00628055344025·The GenePOC™ CDiff assay performed on the revog...

    MOCK PIE

    FDA UDI
    GenePoc Inc·00628055344032·The MOCK PIE is a re-usable PIE intended for us...

    GenePOC™ GBS LB

    FDA UDI
    GenePoc Inc·00628055344018·The GenePOC™ GBS LB assay performed on the revo...

    GenePOC™ Carba

    FDA UDI
    GenePoc Inc·00628055344070·The GenePOC™ Carba assay, performed on the revo...

    xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto, Ontario Canada Catalog # I030B0373 The xTAG CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples.

    FDA Recall
    Terminated ·Luminex Corporation·Product code NTI·May 24, 2011