Medical device licence · 61680 · Class 2
STANDARDS FOR THE COBAS ISE MODULE
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed January 29, 2003; ended November 4, 2003. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 61680
- Licence holder
- Phoenix Diagnostics Inc.Natick, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- January 29, 2003
- Ended
- November 4, 2003
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ISE INTERNAL REFERENCE
- STANDARD 1 FOR COBAS ISE MODULE
- STANDARD 2 FOR COBAS ISE MODULE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.