ApprovalTrail

Medical device licence · 71732 · Class 2

BILIRUBIN REAGENT

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed June 26, 2006; ended December 7, 2016. It is in Health Canada’s archive of licences no longer in force.
Licence number
71732
Licence holder
Infrared Laboratory Systems LlcWestfield, IN, United States
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
June 26, 2006
Ended
December 7, 2016
Devices covered
5

Devices on this licence

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

  • 700NM TOTAL BILIRUBIN
  • DIRECT BILIRUBIN
  • NEW INFRARED 700NM DIRECT BILIRUBIN
  • TOTAL BILIRUBIN
  • TOTAL BILIRUBIN DS

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