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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tryptase assay system
Definition An in vitro diagnostic device intended as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.
Product CodeOYL
Regulation Number 866.5760
Device Class 2


Premarket Reviews
ManufacturerDecision
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 1
PHADIA US INC.
  GRANTED 1

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