Microbiology Devices; Reclassification of Mycobacterium tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests
🏛 Food and Drug Administration (FDA)FDA-2026-N-2590
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3
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4
all analyzed
Comment status
Closed
Last activity
May 29, 2026
In this docket
Documents
Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
Supporting & Related MaterialApr 20, 2026
Reference 1 - P010033 Approval Order- Supporting & Related Material· Apr 20, 2026