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U.S. Department of Health and Human Services

Product Classification
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Device assay, nucleic acid amplification, bacillus anthracis
Regulation Description In vitro diagnostic device for Bacillus spp. detection.
Definition An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNHT
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		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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