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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device to detect and identify selected microbial agents that cause acute febrile illness
Definition A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors.
Product CodeQMV
Regulation Number 866.3966
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOFIRE DEFENSE, LLC
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

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