Microbiology Devices; Reclassification of Mycobacterium tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests | Federal Regulations · Congress.wiki

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FDA-2026-N-2590

Microbiology Devices; Reclassification of Mycobacterium tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests

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Description

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Key Dates

Comment Period OpensMar 30, 2026

Comment Period ClosesMay 30, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	Reference 2 - 2001 Microbiology Devices Panel Meeting Summary	Apr 20, 2026	--

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Keywords

CDRH

FRDTS # 2024-216

Microbiology Devices

Reclassification of Mycobacterium tuberculosis

Cell-Mediated Immunity Tests and

Immune Response Enzyme-Linked Immunospot Tests

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