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Zdrowie i gospodarka · 30.03.2026

FDA Proposes Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests

The FDA proposes to reclassify Mycobacterium tuberculosis cell-mediated immunity tests and enzyme-linked immunospot tests from class III to class II devices, requiring premarket notification, to ensure safety and effectiveness.

Source: Federal Register — Food and Drug AdministrationOpen original release →