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U.S. Department of Health and Human Services

Product Classification

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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
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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  • Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp.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
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