ApprovalTrail

Medical device licence · 83836 · Class 2

MYOGENIN

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed August 31, 2010; ended October 12, 2021. It is in Health Canada’s archive of licences no longer in force.
Licence number
83836
Licence holder
Biocare Medical, LlcPacheco, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
August 31, 2010
Ended
October 12, 2021
Devices covered
3

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • INTELLIPATH FLX MYOGENIN (PREDILUTED MONOCLONAL ANTIBODY)
  • MYOGENIN (CONCENTRATED MONOCLONAL ANTIBODY)
  • MYOGENIN (PREDILUTED MONOCLONAL ANTIBODY)

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.