7 results
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45ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·April 29, 2026
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·April 29, 2026
FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·December 3, 2025
FoundationOne Companion Diagnostic (F1CDx)
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·June 11, 2025
FoundationOne Companion Diagnostic (F1CDx)
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·June 11, 2025
FoundationOne Companion Diagnostic (F1CDx)
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·May 21, 2025
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·December 3, 2025