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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
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.
Review Panel Microbiology
Product CodeNRL
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
Guidance Document
  • Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection
Third Party Review Not Third Party Eligible
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