2 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
FDA Enforcement
Class II
·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·December 26, 2018
Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
FDA Recall
Terminated
·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018