![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » FDA Clears Abbott’s Influenza and Strep Assays
FDA Clears Abbott’s Influenza and Strep Assays
![ClearanceStamp_Blue.gif](https://www.fdanews.com/ext/resources/test/Device_Images6/ClearanceStamp_Blue.gif?t=1576043968&width=430)
October 26, 2018
Abbott’s next-generation influenza A&B and strep A assays have been given 510(k) clearance by the FDA and are now available on the ID NOW platform, formerly known as the Alere I platform.
The A&B assay offers results in 13 minutes or less, with early call out for positive results in as little as five minutes, while the Strep assay’s results are ready in six minutes or less, with positive results available in as little as two minutes.
The assay’s early positive results enable prompt treatment decisions.
Upcoming Events
-
21Oct