2 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·May 26, 2021
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·May 26, 2021