![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 » Hologic Gains CE Mark for Use of Saliva Samples with Its COVID-19 Test
Hologic Gains CE Mark for Use of Saliva Samples with Its COVID-19 Test
![Hologic logo](https://www.fdanews.com/ext/resources/test/Device_Images6/Hologic_Logo.gif?t=1624653890&width=430)
Hologic has obtained a CE mark for the use of saliva samples with its Aptima COVID-19 assay.
The molecular diagnostic assay detects the genetic material of the SARS-CoV-2 coronavirus that causes COVID-19 infections.
Marlborough, Mass.-based Hologic, which mainly focuses on the detection and treatment of illness in women, developed the Covid-19 assay in response to the pandemic. The assay runs on the company’s automated Panther system.
Upcoming Events
-
11Jul
-
18Jul
-
21Oct