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U.S. Department of Health and Human Services

Product Classification

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Device norovirus serological reagent
Regulation Description Norovirus serological reagents.
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.
Physical State Laboratory kit.
Technical Method ELISA-based or immunological based assays.
Target Area Human biological specimens.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOUC
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3395
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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