• 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 cardiac c-reactive protein, antigen, antiserum, and control
Regulation Description C-reactive protein immunological test system.
Definition In vitro diagnostic test to measure c-reactive protein for the purpose of making cardiac risk assessments.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNQD
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5270
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-