Quidel Corporation

Quidel Corporation — FDA 510(k) Submissions

Quidel Corporation has submitted 37 FDA 510(k) premarket notifications since 2010, of which 35 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System, Devices Detecting Influenza A, B, And C Virus Antigens, Antigens, All Groups, Streptococcus Spp., Reagent, Borrelia Serological Reagent, Respiratory Virus Panel Nucleic Acid Assay System . Use the specialty filter in the sidebar to narrow results.