Medical device licence · 35901 · Class 3
ONKO-SURE
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed January 25, 2002; ended December 6, 2012. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 35901
- Licence holder
- Amdl Diagnostics, Inc.Tustin, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- January 25, 2002
- Ended
- December 6, 2012
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DR-70 (FDP) ELISA TUMOR MARKER
- ELIZA DR-70 ANTIBODY TEST KIT
- ONKO-SURE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.