ApprovalTrail

Medical device licence · 3345 · Class 2

CREATININE REAGENTS

No longer licensed: cancelled: quality-system requirement (2003)

Licence status Cancelled: quality-system requirement (2003); first licensed May 25, 1999; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
Licence number
3345
Licence holder
Infrared Laboratory Systems LlcWestfield, IN, United States
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
May 25, 1999
Ended
February 16, 2004
Devices covered
2

Devices on this licence

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

  • CREATININE REAGEN PREOXIDIZED KIT
  • CREATININE REAGENT KIT

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