We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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. Read More
The U.S. Food and Drug Administration’s authority to reconsider and rescind earlier classification decisions could be severely limited following a recent federal court ruling. Read More
Manufacturers of nucleic acid amplification test reagents for dengue virus should take a variety of steps, such as optimizing reagents and test procedures for recommended instruments, to prevent false negative or positive results, the U.S. Food and Drug Administration says. Read More