06/19/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 6/19/2020. This Food and Drug Administration (FDA) letter recommends that clinical laboratories and health care providers stop using COVID-19 antibody tests that are listed on FDA’s “removed” test list. The “removed” test list includes tests where significant clinical performance problems were identified that cannot be or have not been addressed by the commercial manufacturer in a timely manner, tests for which an Emergency Use Authorization request has not been submitted by a commercial manufacturer of a serology test within a reasonable period of time as outlined in FDA’s guidance, and tests voluntarily withdrawn by the respective commercial manufacturers. (Text)
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