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U.S. Department of Health and Human Services

Product Classification

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Device gas chromatography, bacillus anthracis membrane fatty acids
Definition Aid in the identification of bacillus anthracis.
Physical State 25 x 0.2 mm capillary column (0.33-film thickness of 5% diphenyl-95%-dimethyl siloxane), an oven with 170-270aC increase range during analysis, an autoinjector, MIDI Sherlock Microbial Identification System software that includes the BTR library, and a calibration standard
Technical Method gas chromatography and pattern recognition
Target Area trypticase soy agar (with 5% sheep blood) bacterial cultures of any specimen type from the human body
Review Panel Microbiology
Product CodeNWZ
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  • Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp.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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible