emergency use authorization
Roche Molecular Respiratory Virus Panel Receives FDA Emergency Use Authorization
The PCR-based test detects SARS-CoV-2, influenza A/B, and respiratory syncytial virus from a nasal swab sample.
Labcorp Receives FDA Emergency Use Authorization for Mpox Test Home Collection Kit
The kit is the first mpox home collection kit authorized by FDA and is meant for the collection of specimens via lesion swab in patients suspected of mpox infection.
Lighthouse Lab Services Molecular Saliva Test for SARS-CoV-2 Gets FDA Emergency Use Authorization
The test uses RT-PCR for the detection in saliva of SARS-CoV-2 nucleic acid in individuals suspected by their healthcare provider of being infected with the virus.
Labcorp, CDC Receive FDA EUA for Sample Collection Kit, Molecular Mpox Assay
The CDC test is intended for the qualitative detection of DNA from non-variola Orthopoxvirus in human pustular or vesicular rash specimens.
FDA Grants Emergency Use Authorization for Tetracore COVID-19 PCR Test
The test is designed for the qualitative detection of SARS-CoV-2 nucleic acid in mid-turbinate nasal swab specimens.