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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dengue serological reagents
Definition Dengue virus serological reagents are devices that consist of antigens and antisera for the detection of anti-dengue antibodies, individuals that have signs and symptoms consistent with dengue. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue virus. The device is intended for use in the presumptive diagnosis of patients in conjunction with other clinical and laboratory findings.
Product CodeOSU
Regulation Number 866.3945
Device Class 2


Premarket Reviews
ManufacturerDecision
INBIOS INTL., INC.
  GRANTED 1

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