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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dengue virus antigen assay
Definition Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection
Product CodeQCU
Regulation Number 866.3945
Device Class 2


Premarket Reviews
ManufacturerDecision
INBIOS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

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