FDA Downgrades Molecular Tuberculosis Assays To 510(k) Status
This article was originally published in The Pink Sheet Daily
FDA has reclassified nucleic acid-based diagnostics to detect tuberculosis from respiratory specimens to class II with special controls, moving the rapid tests to a 510(k) rather than PMA standard. Also, the agency codified its prior downclassification of dengue virus serological reagents.
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