Medical device licence · 671 · Class 2
COBAS INTEGRA SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 7, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 671
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 7, 1999
- Devices covered
- 22
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS INTEGRA SYSTEM - AMPHETAMINES
- COBAS INTEGRA SYSTEM - BARBITURATES
- COBAS INTEGRA SYSTEM - CHOLINESTERASE (CHE)
- COBAS INTEGRA SYSTEM - COBAS INTEGRA 400 ANALYZER - CLASS 2
- COBAS INTEGRA SYSTEM - COCAINE II
- COBAS INTEGRA SYSTEM - COCAINE METABOLITES
- COBAS INTEGRA SYSTEM - CONTROL PRECIPATH L
- COBAS INTEGRA SYSTEM - HDL-CHOLESTEROL DIRECT (HDL-D)
- COBAS INTEGRA SYSTEM - ISE CALIBRATORS
- COBAS INTEGRA SYSTEM - ISE SOLUTIONS
- COBAS INTEGRA SYSTEM - LIDOCAINE
- COBAS INTEGRA SYSTEM - LITHIUM ELECTRODE
- COBAS INTEGRA SYSTEM - METHAQUALONE
- COBAS INTEGRA SYSTEM - PHENCYCLIDINE
- COBAS INTEGRA SYSTEM - PRECINORM-L
- COBAS INTEGRA SYSTEM - PROPOXYPHENE
- COBAS INTEGRA SYSTEM - QUINIDINE
- COBAS INTEGRA SYSTEM - SALICYLATE
- COBAS INTEGRA SYSTEM - SERUM BARBITURATES (SBARB)
- COBAS INTEGRA SYSTEM - SERUM BENZODIAZEPINE (SBENZ)
- COBAS INTEGRA SYSTEM - VANCOMYCIN ASSAY
- COBAS INTEGRA SYSTEMS - CHOLINESTERASE/DIBICAIN (CHE-D)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.