An EUA can be issued only after the secretary of health and human services has declared a public health emergency. In the case of the 2009 H1N1 influenza pandemic, such a declaration was made on ...

The FDA has notified healthcare professionals that it has issued an Emergency Use Authorization (EUA) for intravenous ... confirmed or suspected 2009 H1N1 influenza infection who are admitted ...

It is the first such test to receive an Emergency Use Authorization (EUA) from the FDA. "Today's authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2 ...

FDA Authorizes Emergency Use of H1N1 Influenza Virus Test Jul 29, 2009 The Food and Drug Administration today announced it has issued an Emergency Use Authorization (EUA) for a another diagnostic ...

Still, the test was able to spot the virus in “contrived specimens,” according to the FDA, and its maker is required by the EUA to continue collecting real-world samples of influenza B for ...

today announced that its UltraPlex 1-Step ToughMix was recognized as part of the new emergency use authorization (EUA) for the Centers for Disease Control and Prevention (CDC) Influenza SARS-CoV-2 ...

Eventually, the company redesigned the test. In addition, the EUA request included only nine positive influenza A clinical samples that FDA considered insufficient to determine test performance ...

Conjunctival and nasopharyngeal swab specimens were obtained from the right eye for influenza testing. The results of real-time reverse-transcription–polymerase-chain-reaction (RT-PCR ...

Lucira's request for an EUA for its at-home Covid-flu test included only nine positive influenza A samples, "an amount we found was insufficient to adequately determine test performance and ...