9 results
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52ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
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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 test report
FDA Enforcement
Class II
·Terminated·Foundation Medicine, Inc.·December 4, 2019
FoundationOne CDx Test Results
FDA Enforcement
Class II
·Terminated·Foundation Medicine, Inc.·December 26, 2018
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·December 3, 2025