Digene Corp.

Digene Corp. — FDA 510(k) Submissions

Digene Corp. has submitted 9 FDA 510(k) premarket notifications since 1997, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dna-reagents, Chlamydia, Dna-reagents, Neisseria, Colorimeter, Photometer, Spectrophotometer For Clinical Use, Spatula, Cervical, Cytological, Antigen, Iha, Cytomegalovirus . Use the specialty filter in the sidebar to narrow results.