Abbott said its BinaxNOW® Influenza A & B Card 2 has been granted waived status by the Food and Drug Administration for use with Abbott’s DIGIVALTM diagnostic reader. The rapid influenza diagnostic test allows faster diagnosis of flu.
The reader interprets BinaxNOW Influenza A & B Card 2 tests in seconds, delivering automated and objective results for providers. The combined platform is expected to be used in laboratories, walk-in clinics and other healthcare settings.
“This flu season, healthcare providers need objective tests that can provide fast, accurate results to determine the best course of care for patients,” said Sharon Bracken, senior vice president, Rapid Diagnostics, Abbott. “The BinaxNOW Influenza A & B Card 2 adds to our strong portfolio of rapid flu tests by providing rapid and easy diagnosis, while DIGIVAL enhances healthcare providers’ confidence in results by reducing user subjectivity.”
As a Class II assay, the BinaxNOW Influenza A & B Card 2 meets the FDA’s new reclassification requirements for RIDTs.