Medical device licence · 712 · Class 2
ROCHE HITACHI
Yes: licensed in Canada
Licence status Issued (active); first licensed January 13, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 712
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 13, 1999
- Devices covered
- 33
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ROCHE HITACHI - ALBUMIN (BCP)
- ROCHE HITACHI - ALT (IFCC)
- ROCHE HITACHI - ALT (OPT)
- ROCHE HITACHI - ANTITHROMBIN III
- ROCHE HITACHI - APOLIPOPROTEIN A1
- ROCHE HITACHI - APOLIPOPROTEIN B
- ROCHE HITACHI - AST (OPT)
- ROCHE HITACHI - BILIRUBIN (DIRECT)
- ROCHE HITACHI - C3 COMPLEMENT
- ROCHE HITACHI - C4 COMPLEMENT
- ROCHE HITACHI - CARBAMAZEPINE
- ROCHE HITACHI - CRP
- ROCHE HITACHI - FOLATE
- ROCHE HITACHI - HBA1C
- ROCHE HITACHI - MODULAR PP/DP
- ROCHE HITACHI - ONLINE BARBITURATES
- ROCHE HITACHI - ONLINE COCAINE METABOLITE
- ROCHE HITACHI - ONLINE PHENCYCLIDINE
- ROCHE HITACHI - ONLINE TDM QUINIDINE
- ROCHE HITACHI - ONLINE TDM VANCOMYCIN
- ROCHE HITACHI - PHENOBARBITAL
- ROCHE HITACHI - PHENYTOIN
- ROCHE HITACHI - PRE-ALBUMIN
- ROCHE HITACHI - RBC FOLATE
- ROCHE HITACHI - SALICYLATE
- ROCHE HITACHI - T-UPTAKE
- ROCHE HITACHI - THEOPHYLLINE
- ROCHE HITACHI - TOBRAMYCIN
- ROCHE HITACHI - VALPROIC ACID
- ROCHE HITACHI 917/911/912/902 ANALYZERS - CLASS 2
- ROCHE HITACHI ASLO (ANTI-STREPTOLYSIN O)
- ROCHE HITACHI LDL - CPLUS CALIBRATOR AND CONTROLS
- ROCHE HITACHI SYSTEM 704/717/747 ANALYZERS - CLASS 2
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.