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

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device lower respiratory microbial nucleic acid detection system
Regulation Description Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
Definition Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
Physical State In vitro diagnostic device consisting of reagents and associated instrumentation for detection of nucleic acid sequences from microorganisms and associated resistance markers in lower respiratory specimens.
Technical Method In vitro diagnostic device that detects and identifies nucleic acid sequences from microorganisms and associated resistance markers in lower respiratory specimens.
Target Area Respiratory specimens from patients with signs and symptoms of respiratory infection.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQBH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3985
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-