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U.S. Department of Health and Human Services

Product Classification

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Device kit, immunochromatographic, bacillus anthracis differential antibody
Regulation Description In vitro diagnostic device for Bacillus spp. detection.
Definition A serological reagent to distinguish b. Anthracis culture growth from other bacillus spp. Growth
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNPO
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible