![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FDA Authorizes Two Siemens COVID-19 Tests
FDA Authorizes Two Siemens COVID-19 Tests
Two COVID-19 tests made by Siemens Healthcare Diagnostics have received Emergency Use Authorization (EUA) from the FDA.
The Tarrytown, N.Y.-based subsidiary of the German tech giant has garnered the EUAs for its ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) and Atellica IM (immunoassay) SARS-CoV-2 Antigen (CoV2Ag) tests.
The two immunoassays detect SARS CoV-2 nucleocapsid antigen from anterior nasal swab specimens from individuals who are suspected of COVID-19 infection by their healthcare providers within the first seven days of symptom onset.
Analysis of the tests is limited to laboratories that are certified to perform moderate- or high-complexity tests.
Upcoming Events
-
11Jul
-
18Jul
-
21Oct