Norovirus Serological Reagent
Norovirus Serological Reagent is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.
US Regulatory Classifications
Device Characteristics
No
No
No
Not Eligible
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.
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