Medical device licence · 95531 · Class 2
PD-1
Yes: licensed in Canada
Licence status Issued (active); first licensed August 5, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95531
- Licence holder
- Biocare Medical, LlcPacheco, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- August 5, 2015
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PD-1 CONCENTRATED MONOCLONAL ANTIBODY
- PD-1 PREDILUTED MONOCLONAL ANTIBODY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.