BEUDAMED
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    ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories·July 4, 2012

    Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part

    FDA Enforcement
    Class I ·Terminated·STEP-HAR MEDICAL LLC·May 19, 2021