![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 » Meridian Bioscience’s Illumigene Mycoplasma Test Nabs FDA Clearance
Meridian Bioscience’s Illumigene Mycoplasma Test Nabs FDA Clearance
![](https://www.fdanews.com/ext/resources/test/Device_Images4/FDA_Logo_Large.gif?t=1486528488&width=430)
The FDA has granted clearance to Meridian Bioscience’s Illumigene Mycoplasma Direct assay for the diagnosis of mycoplasma pneumonia.
The updated assay includes a three-step procedure, producing results in less than an hour, according to the company.
The test uses throat swabs to detect infection on the first day of symptoms. — Anisa Jibrell
Upcoming Events
-
21Oct