# Digene Diagnostics, Inc.

- Location (FDA's records): Silver Spring, MD
- FDA decisions: 1 (1995–1995): 1 510(k) clearance
- Product codes: JJQ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K940486: Digene DCR-1 Luminometer (Apr 18, 1995)

Source page: https://510kreport.com/company/digene-diagnostics