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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device joint biological agent identification and diagnostic system (jbaids) tularemia detection kit
Definition To aid in the diagnosis of individuals presenting with signs and symptoms of pneumonic or typhoidal tularemia with a qualitative in vitro diagnostic (ivd) detection of target dna sequences of francisella tularensis.
Product CodeOEH
Regulation Number 866.3280
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOFIRE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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