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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device circulating tumor cell (ctc) enrichment device
Definition A circulating tumor cell enrichment device is an in vitro diagnostic device used to enrich circulating tumor cells from the peripheral blood of patients diagnosed with cancer for subsequent in vitro diagnostic testing.
Product CodeQSA
Regulation Number 866.6110
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGLE EUROPE LTD.
  GRANTED 1

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