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 Code | OUC |
Regulation Number |
866.3395
|
Device Class |
2
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