On June 5, 2013, the FDA issued an Emergency Use Authorization (EUA) for the CDC Novel Coronavirus 2012 Real-time RT-PCR Assay. This test is for the presumptive detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV), formerly known as Novel Coronavirus 2012 or NCV-2012, in patients with signs and symptoms of MERS-CoV infection in conjunction with clinical and epidemiological risk factors. This device will be distributed by CDC to qualified laboratories.
* Note that the Secretary’s determination and declaration were issued based on revised authorities under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA).
|Diagnostic Test||Date||Letter of|
|Fact Sheet for Healthcare Providers||Fact Sheet for Patients||Labeling (PDF)|
|CDC Novel Coronavirus 2012 Real-time RT-PCR Assay||6/5/13||[Authorization]||[Healthcare]||[Patients]||[Labeling]|