Medical device licence · 3103 · Class 2
COBAS CORE SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed May 17, 1999; ended October 26, 2010. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 3103
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 17, 1999
- Ended
- October 26, 2010
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS CORE SYSTEM - ANALYZER - CLASS 2
- COBAS CORE SYSTEM - ANTI-B2-GLYCOPROTEIN EIA ASSAY
- COBAS CORE SYSTEM - ANTI-DS DNA
- COBAS CORE SYSTEM - ANTI-H PYLORI
- COBAS CORE SYSTEM - ANTI-HAV
- COBAS CORE SYSTEM - ANTI-HAV IGM
- COBAS CORE SYSTEM - ANTI-M PYLORI
- COBAS CORE SYSTEM - B2-MICROGLOBULIN
- COBAS CORE SYSTEM - CRP EIA QUANT ASSAY
- COBAS CORE SYSTEM - HEP 2 ANA
- COBAS CORE SYSTEM - MCA (MUCIN-LIKE CARCINOMA ASSOCIATED ANTIGEN)
- COBAS CORE SYSTEM - NEGATIVE CONTROL AUTO-IMMUNITY
- COBRA CORE SYSTEM - NSE (NEURON SPECIFIC ENOLAS)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.