BEUDAMED
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    Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B; The product is manufactured by: BioGenex Laboratories, Inc. 4600 Norris Canyon Road San Ramon, CA 94583 and Distributed by: Abbott Molecular, 1300 E. Touhy Ave - 2E, Des Plaines, IL 60018 Xmatrx Automated Staining System is intended for in vitro diagnostic use. It is suitable for fluorescent hybridization (FISH) applications.

    FDA Recall
    Terminated ·Biogenex Laboratories·Product code KEY·January 23, 2009

    InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Biogenex Laboratories, Inc.·July 30, 2014

    InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.

    FDA Recall
    Terminated ·Biogenex Laboratories, Inc.·Product code MVC·July 1, 2014