Medical device licence · 3045 · Class 3
DIGENE DCR-1 CAPTURE SYSTEMS
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed June 9, 1999; ended October 19, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 3045
- Licence holder
- Qiagen Gaithersburg, Inc.Gaithersburg, MD, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 9, 1999
- Ended
- October 19, 2004
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIGENE DCR-1 CAPTURE SYSTEM -CLASS 3 ANALYZER
- DIGENE DCR-1 HYBRID CAPTURE SYSTEM - HBV DNA ASSAY
- DIGENE DCR-1 HYBRID CAPTURE SYSTEM CMV DNA ASSAY
- DIGENE DCR-1 HYBRID CAPTURE SYSTEM HPV DNA ASSAY
- DIGENE DML-2000 HYBRID CAPTURE SYSTEM HBV DNA ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.