# Digene Corp.

- Location (FDA's records): Beltsville, MD
- FDA decisions: 9 (1997–2001): 9 510(k) clearances
- Product codes: LSK (3), LSL (3), JJQ (1), LJO (1), HHT (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gen-Probe, Inc.: 2 (https://510kreport.com/company/gen-probe)
- Dynatech Laboratories, Inc.: 1 (https://510kreport.com/company/dynatech-laboratories)
- Incstar Corp.: 1 (https://510kreport.com/company/incstar)
- Donald G. Zeller: 1 (https://510kreport.com/company/donald-g-zeller)

## Firms that cite its devices most
- Molecular Diagnostics: 1 (https://510kreport.com/company/molecular-diagnostics)
- Doctor'S Research Group, Inc.: 1 (https://510kreport.com/company/doctor-s-research-group)
- Fas Medical, Ltd.: 1 (https://510kreport.com/company/fas-medical)

## Its most-cited devices
- K971586: Digene Cervical Brush (1997), cited by 3

## Recent decisions
- K010891: Modification to Hybrid Capture II CT/GC Test, Model 03M90-01 (Sep 25, 2001)
- K010893: Modification to Hybrid Capture 2 GC-ID Dna Test, Model 03M92-01 (Sep 24, 2001)
- K010892: Modification Hybrid Capture II CT-ID Dna Test, Model 03M91-01 (Sep 24, 2001)
- K981567: Hybrid Capture II CT/GC Test (Feb 29, 2000)
- K981485: Hybrid Capture II GC-ID (Nov 29, 1999)
- K990023: Hybrid Capture II CT-ID Test (Oct 25, 1999)
- K974901: Hybrid Capture System CMV Dna Assay (Sep 29, 1998)
- K980120: Digene DML 2000 Microplate Luminometer (Feb 6, 1998)

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