Medical device licence · 81083 · Class 2
P63
Yes: licensed in Canada
Licence status Issued (active); first licensed November 3, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 81083
- Licence holder
- Biocare Medical, LlcPacheco, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 3, 2009
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MONOCLONAL MOUSE ANTI-HUMAN P63 CONCENTRATE
- MONOCLONAL MOUSE ANTI-HUMAN P63 PREDILUTE
- P63 (PREDILUTED MONOCLONAL ANTIBODY)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.