NEW YORK – The US Food and Drug Administration last week released revisions to Abbott Laboratories' Emergency Use Authorization for its point-of-care ID Now test.
Those revisions include an update to the intended use to clarify that the test is for specimens collected within a week of symptom onset and is authorized for CLIA-certified labs that can perform high, moderate, or waived complexity tests. The intended use was also amended to clarify results reporting requirements for testing facilities.