ApprovalTrail

Medical device licence · 74998 · Class 2

SYSMEX HEMATOLOGY REAGENTS

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed October 2, 2007; ended October 2, 2020. It is in Health Canada’s archive of licences no longer in force.
Licence number
74998
Licence holder
Sysmex Reagents AmericaLos Alamitos, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
October 2, 2007
Ended
October 2, 2020
Devices covered
26

Devices on this licence

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

  • CELLPACK
  • CELLPACK DCL
  • CELLPACK DST
  • CELLPACK-3D (II)
  • CELLPACK-S CONCENTRATE
  • CELLSHEATH
  • CELLSHEATH CCS
  • CELLSHEATH-C
  • LYSERCELL WDF
  • LYSERCELL WNR
  • MANORESH
  • PARTICLE SHEATH
  • STROMATOLYSER-3D II
  • STROMATOLYSER-3WP
  • STROMATOLYSER-4DL
  • STROMATOLYSER-4DS
  • STROMATOLYSER-BA
  • STROMATOLYSER-EO II
  • STROMATOLYSER-FB
  • STROMATOLYSER-FD I
  • STROMATOLYSER-FD II
  • STROMATOLYSER-IM
  • STROMATOLYSER-NR
  • STROMATOLYSER-NR(L)
  • STROMATOLYSER-WH
  • SULFOLYSER

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