3 results
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46ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.
FDA Enforcement
Class II
·Ongoing·CARIS LIFE SCIENCES·September 10, 2025
MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.
FDA Recall
Open, Classified
·CARIS LIFE SCIENCES·Product code PQP·June 17, 2025
ALARIS SECONDARY SET
FDA Adverse Event
Injury
·CAREFUSION·Product code FPA·September 10, 2018