BEUDAMED
    2 results · 12ms · Sources: EU EUDAMED, US FDA

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    ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.

    FDA Enforcement
    Class II ·Terminated·Innominata Dba Genbio·March 20, 2013

    XP-CR Tibial Tray - Interlok 67mm Item # 195271

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019