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 bacteriophage and controls, b. anthracis lysis
Definition A gamma phage lysis assay intended for the identification of bacillus anthracis from non-hemolytic, aerobic gram positive colonies isolated from sheep blood agar.To aid in the laboratory identification of bacillus anthracis culture growth by lysis with a specific bacteriophage.
Physical State Cultured isolates
Technical Method Bacteriophage, culture
Target Area Systemic
Review Panel Microbiology
Product CodeNVQ
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection
Third Party Review Not Third Party Eligible
-
-