Medical device licence · 97959 · Class 4
PROCLEIX PANTHER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 4, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97959
- Licence holder
- Hologic, Inc.Sunnyvale, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- November 4, 2016
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CONTINUOUS ACCESS KIT WITH ASSEMBLED WASTE DRAWER
- MTU EXPANSION KIT
- PROCLEIX PANTHER ASSAY SOFTWARE
- PROCLEIX PANTHER SYSTEM
- PROCLEIX PANTHER SYSTEM (ART, CONTINUOUS FLUID AND WASTE)
- PROCLEIX PANTHER SYSTEM SOFTWARE
- TRACK READY SHUTTLE MODULE
- WASTE TO DRAIN KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.