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U.S. Department of Health and Human Services

Product Classification

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Device enzyme linked immunoabsorbent assay, antibody, b. anthracis
Regulation Description In vitro diagnostic device for Bacillus spp. detection.
Definition The elisa assay for antibodies to b. Anthracis is used to detect an immunological response to proteins secreted by b. Anthracis; As an aid in the laboratory diagnosis of anthrax.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNRL
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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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