ApprovalTrail

Medical device licence · 99416 · Class 2

ALINITY H SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed July 14, 2017. It is in Health Canada’s list of active licences.
Licence number
99416
Licence holder
Abbott Laboratories Co.Saint-Laurent, Quebec, Canada
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
July 14, 2017
Devices covered
4

Devices on this licence

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

  • ALINITY H SYSTEM SOFTWARE
  • ALINITY H-SERIES SYSTEM CONTROL CENTER, CPU
  • ALINITY HQ ANALYZER
  • ALINITY HS SLIDE MAKER STAINER MODULE

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