• 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 kit, immunochromatographic, bacillus anthracis differential antibody
Regulation Description In vitro diagnostic device for Bacillus spp. detection.
Definition A serological reagent to distinguish b. Anthracis culture growth from other bacillus spp. Growth
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNPO
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3045
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
-
-