Medical device licence · 753 · Class 3
IMMUNOASSAY ANALYZERS
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed January 18, 1999; ended October 28, 2016. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 753
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- January 18, 1999
- Ended
- October 28, 2016
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELECSYS 1010 IMMUNOASSAY ANALYZER
- ELECSYS 2010 IMMUNOASSAY ANALYZER
- ELECSYS AFP
- ELECSYS CA 125 II
- ELECSYS CA 15-3
- ELECSYS CEA
- ELECSYS CK-MB
- ELECSYS CK-MB (STAT)
- ELECSYS CYFRA 21-1
- ELECSYS FREE PSA
- ELECSYS HCG
- ELECSYS PSA
- ELECSYS TROPONIN T
- ELECSYS TROPONIN T (STAT)
- ELECYS MYOGLOBIN STAT
- PRECICONTROL
- PRECICONTROL CARDIAC
- PRECICONTROL UNIVERSAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.