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The agency said that sensitivity below 80 percent will not be considered acceptable for authorization because the tests could produce too many false negative results. Read More
“Nontuberculous mycobacteria (NTM) patient infections, NTM device contamination and, in some cases, both issues have now been reported for all manufacturers of heater-cooler devices in the U.S.,” the FDA noted. Read More
In evaluations of its test, Abbott found that it provided 99.56 percent specificity and 95 percent sensitivity for patients tested 15 days after symptom onset. Read More
Sponsors that import or supply devices in Australia would need to verify that device manufacturers have assigned a UDI to their device and have placed it on the device, on labeling and on packaging. Read More