Medical device licence · 74251 · Class 3
COBAS B221 SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed June 19, 2007; ended May 26, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 74251
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 19, 2007
- Ended
- May 26, 2015
- Devices covered
- 21
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS B221 SYSTEM - AUTO-TROL B PLUS
- COBAS B221 SYSTEM - AUTO-TROL TS+
- COBAS B221 SYSTEM - CALCIUM (CA) ELECTRODE
- COBAS B221 SYSTEM - CHLORIDE (CL) ELECTRODE
- COBAS B221 SYSTEM - COMBITROL B PLUS
- COBAS B221 SYSTEM - COMBRITOL TS+
- COBAS B221 SYSTEM - FLUID PACKS
- COBAS B221 SYSTEM - GLUCOSE MSS CARTRIDGE
- COBAS B221 SYSTEM - GLUCOSE/LACTATE MSS CARTRIDGE
- COBAS B221 SYSTEM - GLUCOSE/LACTATE/UREA MSS CARTRIDGE
- COBAS B221 SYSTEM - HB CALIBRATOR
- COBAS B221 SYSTEM - INSTRUMENTS
- COBAS B221 SYSTEM - OM,NI SOL CTRL COOX/MSS VERIFICATION
- COBAS B221 SYSTEM - PCO2 ELECTRODE
- COBAS B221 SYSTEM - PO2 ELECTRODE
- COBAS B221 SYSTEM - POTASSIUM (K) ELECTRODE
- COBAS B221 SYSTEM - REFERENCE ELECTRODE
- COBAS B221 SYSTEM - RINSE SOLUTIONS
- COBAS B221 SYSTEM - SODIUM (NA) ELECTRODE
- COBAS B221 SYSTEM - SOFTWARE V7.0
- COBAS B221 SYSTEM - TS/MSS VERIFICATION MATERIAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.