Medical Device Manufacturer · US , Gaithersburg , MD

Digene Corp. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1997

Recent clearances: MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01, MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01, MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01

View 9 510(k) Devices ↓

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Digene Corp. Obstetrics & Gynecology ✕

1 devices

1-1 of 1

Cleared Sep 19, 1997

DIGENE CERVICAL BRUSH

Obstetrics & Gynecology · 141d