• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
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.
Product CodePIQ
Regulation Number 866.3990
Device Class 2