![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 » Alfa Scientific Wins 510(k) Clearance for Multi-Drug of Abuse Assay
Alfa Scientific Wins 510(k) Clearance for Multi-Drug of Abuse Assay
March 2, 2018
Alfa Scientific Designs received 510(k) marketing clearance for its Simple Cup multi-drug of abuse urine immunoassay.
The test identifies thirteen drugs or drug metabolites and provides results in two minutes. The device maintains line integrity for at least two hours with 98.88% accuracy.
The assay is cleared for both professional and home use.
Upcoming Events
-
21Oct