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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 Microorganism differentiation and identification device.
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 and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.2660
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible