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Home » FDA Grants Class II Status to IVDs for Mycobacterium TB Complex
FDA Grants Class II Status to IVDs for Mycobacterium TB Complex
The FDA issued a final rule Wednesday placing nucleic acid-based IVDs for the detection of Mycobacterium tuberculosis complex in Class II with special controls. The rule also covers use of the tests to detect genetic mutations associated with MTB complex antibiotic resistance in respiratory specimens.