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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device biothreat microbial agent nucleic acid detection test
Definition A biothreat microbial agent nucleic acid detection test is a qualitative in vitro diagnostic device for the detection and identification of biothreat microbial agent–associated nucleic acids in human clinical specimens.
Product CodeSGA
Regulation Number 866.4000
Device Class 2


Premarket Reviews
ManufacturerDecision
CENTERS FOR DISEASE CONTROL AND PREVENTION
  SUBSTANTIALLY EQUIVALENT 1

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