Medical device licence · 14845 · Class 3
OPUS SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed December 3, 1999; ended October 27, 2005. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 14845
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 3, 1999
- Ended
- October 27, 2005
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OPUS CEA TEST MODULES
- OPUS CK-MB TEST MODULES
- OPUS INSTRUMENT - CLASS 3
- OPUS MYOGLOBIN TEST MODULES (IMMUNOASSAY)
- OPUS PSA TEST MODULES
- OPUS TROPONIN 1 TEST MODULES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.