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

Nonrulemaking

FDA

Open for Comments

FDA-2026-N-2590

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

Documents

Comments

Description

Open

Key Dates

Comment Period OpensMar 30, 2026

Comment Period ClosesMay 30, 2026

Documents

Type	Title	Posted	Comments	Status
Proposed Rule	Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests FR Doc: 2026-06064	Mar 30, 2026	1

Comment Statistics

Total Comments

Keywords

CDRH

FRDTS # 2024-216

Microbiology Devices

Reclassification of Mycobacterium tuberculosis

Cell-Mediated Immunity Tests and

Immune Response Enzyme-Linked Immunospot Tests

Open

Data from Regulations.gov