Medical device licence · 82590 · Class 2
MLH-1
Yes: licensed in Canada
Licence status Issued (active); first licensed April 16, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82590
- Licence holder
- Biocare Medical, LlcPacheco, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- April 16, 2010
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MLH-1 CONCENTRATED AND PREDILUTED MONOCLONAL ANTIBODY
- MONOCLONAL MOUSE MLH-1 ANTIBODY CONCENTRATE
- MONOCLONAL MOUSE MLH-1 ANTIBODY PREDILUTE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.