Quidel (US) submits 510(k) for one-step allergy test:
This article was originally published in Clinica
Quidel (US) has submitted a 510(k) premarket notification for its one-step allergy test to the FDA. QuickVue one-step allergy screen tests for five common antigens in 15 minutes, using a finger-prick blood sample. Quidel says the worldwide market for in vitro allergy tests is approximately $150 million a year.