2 results
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30ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No. : 447213
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·April 26, 2023
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·August 27, 2025