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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device procalcitonin assay
Definition To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).
Product CodePRI
Regulation Number 866.3215
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1

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