![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 Clears New Indications for Lyme Disease Diagnostics
FDA Clears New Indications for Lyme Disease Diagnostics
![FDA_Logo_Black_2016.gif](https://www.fdanews.com/ext/resources/test/Drug-Images4/FDA_Logo_Black_2016.gif?t=1579040596&width=430)
The FDA has OK’d four diagnostic tests with new indications for diagnosing Lyme disease.
“The tests cleared today are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially” rather than the current two-step Western Blot test, the agency said.
The new assays are easier to interpret in the laboratory due to the streamlined methods for running the tests, CDRH said.
Upcoming Events
-
21Oct