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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 antigens of biothreat microbial agents in human clinical specimens
Definition A device to detect antigens of biothreat microbial agents in human clinical specimens is identified as an in vitro diagnostic device intended for the detection of antigens of microbial agents in specimens collected from patients with signs and symptoms of infection with biothreat microbial agents and who have been exposed to these agents or are suspected or at risk of exposure.  Devices to detect antigens of biothreat microbial agents in human clinical specimens may be used for cadaver testing if the cadaver constitutes a source of human-to-human transmission and if testing is performed to prevent human disease.
Product CodeQID
Regulation Number 866.4002
Device Class 2


Premarket Reviews
ManufacturerDecision
ORASURE TECHNOLOGIES, INC.
  GRANTED 1

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