ApprovalTrail

Medical device licence · 83786 · Class 2

CD3 (M)

Yes: licensed in Canada

Licence status Issued (active); first licensed August 30, 2010. It is in Health Canada’s list of active licences.
Licence number
83786
Licence holder
Biocare Medical, LlcPacheco, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
August 30, 2010
Devices covered
4

Devices on this licence

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

  • INTELLIPATH FLX MOUSE MONOCLONAL ANTI-HUMAN CD3(M) ANTIBODY PREDILUTE
  • MOUSE MONOCLONAL ANTI-HUMAN CD3(M) ANTIBODY CONCENTRATE
  • MOUSE MONOCLONAL ANTI-HUMAN CD3(M) ANTIBODY PREDILUTE
  • VP-ECHELON CD3 (M) (MOUSE MONOCLONAL ANTI-HUMAN, PREDILUTE)

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