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U.S. Department of Health and Human Services

Product Classification

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Device reagents for detection of norovirus nucleic acid
Regulation Description Gastrointestinal microorganism multiplex nucleic acid-based assay.
Definition Qualitative in vitro diagnostic test for the rapid detection and differentiation of norovirus genogroup I and genogroup II from specimens e.g., stool collected from individuals with symptoms of acute gastroenteritis.
Physical State The device/system consists of an instrument, personal computer, and preloaded software for running the tests and viewing the results.
Technical Method Instrument Systems automate and integrate sample preparation, nucleic acid extraction and amplification, and detection of the target sequences in simple or complex samples using reverse transcriptase PCR (RT-PCR) and real-time PCR assays.
Target Area Noninvasive
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePIQ
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3990
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible