Medical device licence · 9565 · Class 2
OPUS SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 10, 1999; ended October 27, 2005. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 9565
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 10, 1999
- Ended
- October 27, 2005
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OPUS SYSTEM - CARBAMAZEPINE ASSAY
- OPUS SYSTEM - DIGOXIN ASSAY
- OPUS SYSTEM - FERRITIN ASSAY
- OPUS SYSTEM - FT4 ASSAY
- OPUS SYSTEM - INSTRUMENT-CLASS 2
- OPUS SYSTEM - PHENOBARBITAL ASSAY
- OPUS SYSTEM - PHENYTOIN ASSAY
- OPUS SYSTEM - T-UPTAKE ASSAY
- OPUS SYSTEM - T4 ASSAY
- OPUS SYSTEM - THEOPHYLLINE ASSAY
- OPUS SYSTEM - THYROID STIMULATING HORMONE (TSH) ASSAY
- OPUS SYSTEM - TOBRAMYCIN ASSAY
- OPUS SYSTEM - TOTAL B-HCG ASSAY
- OPUS SYSTEM - VALPROIC ACID ASSAY
- OPUS SYSTEM - VANCOMYCIN ASSAY
- OPUSSYSTEM - GENTAMICIN ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.