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Digene Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K010891MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01September 25, 2001
K010892MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01September 24, 2001
K010893MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01September 24, 2001
K981567HYBRID CAPTURE II CT/GC TESTFebruary 29, 2000
K981485HYBRID CAPTURE II GC-IDNovember 29, 1999
K990023HYBRID CAPTURE II CT-ID TESTOctober 25, 1999
K974901HYBRID CAPTURE SYSTEM CMV DNA ASSAYSeptember 29, 1998
K980120DIGENE DML 2000 MICROPLATE LUMINOMETERFebruary 6, 1998
K971586DIGENE CERVICAL BRUSHSeptember 19, 1997