Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 orthopedic infection microbial multiplex nucleic acid detection system
Definition A qualitative nucleic acid assay that detects and identifies microbial organisms and antimicrobial resistance markers in clinical specimens to aid in the diagnosis of orthopedic infections.
Physical State In vitro diagnostic device consisting of reagents and associated instrumentation for the detection of microorganism nucleic acid sequences and resistance markers in clinical specimens.
Technical Method Multiplexed nucleic-acid assay
Target Area Clinical specimens from patients suspected of orthopedic infection
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQSN
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3988
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
-
-