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 gonococcal antibody tests
Regulation Description Gonococcal antibody test (GAT).
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLGB
Submission Type PMA
Regulation Number 866.3290
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-