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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device revumenib eligibility detection system
Definition A revumenib eligibility detection system is identified as a prescription in vitro diagnostic device intended for the qualitative detection of structural abnormalities of chromosome 11 in specimens from patients with acute leukemia for the purpose of identifying patients who may benefit from treatment with revumenib, in accordance with the approved therapeutic product labeling.
Product CodeSFS
Regulation Number 864.1885
Device Class 2


Premarket Reviews
ManufacturerDecision
CYTOCELL LIMITED
  GRANTED 1

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