ApprovalTrail

Medical device licence · 60551 · Class 2

ISOTYPIC CONTROLS

Yes: licensed in Canada

Licence status Issued (active); first licensed September 24, 2002. It is in Health Canada’s list of active licences.
Licence number
60551
Licence holder
Beckman Coulter, Inc.San Diego, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
September 24, 2002
Devices covered
22

Devices on this licence

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

  • COULTER CLONE MSIGG1-FITC MONOCLONAL ANTIBODY
  • COULTER CLONE MSIGG1-RD1 MONOCLONAL ANTIBODY
  • COULTER CLONE MSIGG1-RD1 MONOCLONAL ANTIBODY
  • COULTER CLONE MSIGG2A MONOCLONAL ANTIBODY
  • COULTER CLONE MSIGG2A-FITC MONOCLONAL ANTIBODY
  • COULTER CLONE MSIGG2A-RD1 MONOCLONAL ANTIBODY
  • COULTER CLONE MSIGG2B MONOCLONAL ANTIBODY
  • COULTER CLONE MSIGG2B-FITC MONOCLONAL ANTIBODY
  • COULTER CLONE MSIGG2B-RD1 MONOCLONAL ANTIBODY
  • COULTER CLONE MSIGM-FITC MONOCLONAL ANTIBODY
  • COULTER CLONE MSIGM-RD1 MONOCLONAL ANTIBODY
  • CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1/MSLGG1-PC5
  • CYTO-STAT/COULTER CLONE MSIGG1-FITC MONOCLONAL ANTIBODY
  • CYTO-STAT/COULTER CLONE MSIGG1-RD1 MONOCLONAL ANTIBODY
  • CYTO-STAT/COULTER CLONE MSIGG1-RD1/ MSIGG1-FITC MONOCLONAL ANTIBODY
  • CYTO-STAT/COULTER CLONE MSIGG1-RD1/ MSIGG2A-FITC MONOCLONAL ANTIBODY
  • CYTO-STAT/COULTER CLONE MSIGG2A-FITC MONOCLONAL ANTIBODY
  • CYTO-STAT/COULTER CLONE MSIGG2A-RD1 MONOCLONAL ANTIBODY
  • CYTO-STAT/COULTER CLONE MSIGG2B-FITC MONOCLONAL ANTIBODY
  • CYTO-STAT/COULTER CLONE MSIGM-FITC MONOCLONAL ANTIBODY
  • CYTO-STAT/COULTER CLONE MSIGM-RD1 MONOCLONAL ANTIBODY
  • CYTO-STATE TRICHROME MSIGG1-FITC/MSLGG1-RD1/MSLGG1-PC5

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