Digene Corp.
Digene Corp. holds FDA 510(k) medical device clearances, first cleared 1997, most recent 2001.
Top product codes for Digene Corp.
Recent clearances by Digene Corp.
- K010891 — MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
- K010892 — MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
- K010893 — MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01
- K981567 — HYBRID CAPTURE II CT/GC TEST
- K981485 — HYBRID CAPTURE II GC-ID
- K990023 — HYBRID CAPTURE II CT-ID TEST
- K974901 — HYBRID CAPTURE SYSTEM CMV DNA ASSAY
- K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER
- K971586 — DIGENE CERVICAL BRUSH
Data sourced from openFDA. This site is unofficial and independent of the FDA.