Medical device licence · 81375 · Class 3
PROBECHEK CONTROL SLIDES
Yes: licensed in Canada
Licence status Issued (active); first licensed December 4, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 81375
- Licence holder
- Abbott Molecular Inc.Des Plaines, IL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- December 4, 2009
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PROBECHEK ALK NEGATIVE CONTROL SLIDES
- PROBECHEK ALK POSITIVE CONTROL SLIDES
- PROBECHEK HER-2/NEU CUT-OFF CONTROL SLIDES
- PROBECHEK HER-2/NEU NORMAL CONTROL SLIDES
- PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.