ApprovalTrail

Medical device licence · 76003 · Class 4

ACCURUN MULTI-MARKER POSITIVE CONTROLS

Yes: licensed in Canada

Licence status Issued (active); first licensed May 7, 2008. It is in Health Canada’s list of active licences.
Licence number
76003
Licence holder
Lgc Clinical Diagnostics, Inc.Milford, MA, United States
Risk class
Class IV (highest risk)
Licence type
Device Family
First licensed
May 7, 2008
Devices covered
14

Devices on this licence

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

  • ACCURUN 1 MULTI-MARKER POS. CTRLS SER.2600 HTLV HBCAG HCV HBSAG CMV,HIV 1,2
  • ACCURUN 1 MULTI-MARKER POS.CTRLS SER 5100 HTLV HBCAG HCV HBSAG CMV HIV 1,2
  • ACCURUN 1 MULTI-MARKER POS.CTRLS SER. 4700 HTLV HBCAG HCV HBSAG, HIV 1, 2
  • ACCURUN 1 MULTI-MARKER POS.CTRLS SERIES 2500,HTLV HBCAG HCV HBSAG,HIV 1,2
  • ACCURUN 1 MULTI-MARKER POSITIVE CONTROL, SERIES 2400
  • ACCURUN 1 MULTI-MARKER POSITIVE CONTROL, SERIES 2700
  • ACCURUN 1 MULTI-MARKER POSITIVE CONTROL, SERIES 4400
  • ACCURUN 1 MULTI-MARKER POSITIVE CONTROL, SERIES 5600
  • ACCURUN 2 SERIES 2700 MULTI-MARKER POSITIVE CONTROL
  • ACCURUN 24 MULTI-MARKER CONFIRMATORY CONTROL
  • ACCURUN 3 MULTI-MARKER POSITIVE CONTROL
  • ACCURUN 4 MULTI-MARKER POSITIVE CONTROL
  • ACCURUN 5 MULTI-MARKER POSITIVE CONTROL
  • ACCURUN 6 MULTI-MARKER POSITIVE CONTROL

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