ApprovalTrail

Medical device licence · 86234 · Class 2

LUMINEX 200 SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed May 30, 2011; ended October 30, 2013. It is in Health Canada’s archive of licences no longer in force.
Licence number
86234
Licence holder
Luminex CorporationAustin, TX, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
May 30, 2011
Ended
October 30, 2013
Devices covered
11

Devices on this licence

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

  • LUMINEX 200 CALIBRATION KIT
  • LUMINEX 200 IS SOFTWARE, VERSION 2.3
  • LUMINEX 200 PERFORMANCE VERIFICATION KIT
  • LUMINEX 200 SYSTEM
  • LUMINEX 200 XMAP CLASSIFICATION CALIBRATOR
  • LUMINEX 200 XMAP CLASSIFICATION CONTROL
  • LUMINEX 200 XMAP REPORTER CALIBRATOR
  • LUMINEX 200 XMAP REPORTER CONTROL
  • LUMINEX 200 XMAP SHEATH CONCENTRATE PACK
  • LUMINEX 200 XMAP SHEATH FLUID
  • LUMINEX 200 XPONENT 3.1 REV.2

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