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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
Definition A serological reagent to distinguish b. Anthracis culture growth from other bacillus spp. Growth
Review Panel Microbiology
Product CodeNPO
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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