FDA clarifies emergency authorization for Abbott point-of-care test

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FDA clarifies emergency authorization for Abbott point-of-care test
Damareus Barbour CA
Sep 21, 2020

The Food and Drug Administration last week reissued its emergency use authorization for the Abbott ID NOW COVID-19 test to indicate that the product is intended for specimens collected “from individuals who are suspected of COVID-19 by their health care provider within the first seven days of the onset of symptoms.” 

The revised EUA also clarifies that the test is authorized for emergency use by laboratories certified under the Clinical Laboratory Improvement Amendments that meet the requirements to perform high, moderate or waived complexity tests; and that U.S. testing facilities must report all results to the appropriate public health authorities.

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FDA clarifies emergency authorization for Abbott point-of-care test
Damareus Barbour CA
Sep 21, 2020

The Food and Drug Administration last week reissued its emergency use authorization for the Abbott ID NOW COVID-19 test to indicate that the product is intended for specimens collected “from individuals who are suspected of COVID-19 by their health care provider within the first seven days of the onset of symptoms.” 

The revised EUA also clarifies that the test is authorized for emergency use by laboratories certified under the Clinical Laboratory Improvement Amendments that meet the requirements to perform high, moderate or waived complexity tests; and that U.S. testing facilities must report all results to the appropriate public health authorities.

COVID-19: Caring for Patients and Communities
COVID-19: CDC, FDA and CMS Guidance

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