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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
Regulation Description In vitro diagnostic device for Bacillus spp. detection.
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
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNVQ
Premarket Review Office of In Vitro Diagnostics (OHT7)
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		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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