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.