• 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 groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system
Definition An in vitro diagnostic test for the detection of group a, c and g beta hemolytic streptococcus in throat swab specimens from symptomatic patients.
Physical State May include automated/manual isothermal nucleic acid amplification, polymerase chain reaction, ligase chain reaction, sequence-based amplification
Technical Method Uses nucleic acid amplification technology to detect Groups A, C and G Sreptococci
Target Area Throat Swab Specimen
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePGX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.2680
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-