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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
Regulation Description In vitro diagnostic device for Bacillus spp. detection.
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
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNWZ
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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