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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device norovirus serological reagent
Definition Norovirus serological reagents are devices that consist of antigens and antisera for the detection of anti-norovirus antibodies or norovirus antigens. The detection aids in the clinical laboratory diagnosis of norovirus infection in individuals with signs and/or symptoms of acute gastroenteritis, or in the determining the etiology of acute gastroenteritis outbreaks.
Product CodeOUC
Regulation Number 866.3395
Device Class 2


Premarket Reviews
ManufacturerDecision
R-BIOPHARM AG
  GRANTED 1

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