Medical device licence · 113349 · Class 2
ALINITY H SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 20, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113349
- Licence holder
- Abbott Laboratories Co.Saint-Laurent, Quebec, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 20, 2025
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALINITY H SERIES SYSTEM SOFTWARE
- ALINITY H-SERIES AUTOCLEAN SOLUTION
- ALINITY H-SERIES DILUENT
- ALINITY H-SERIES HGB REAGENT
- ALINITY H-SERIES MAY-GRUNWALD-GIEMSA STAIN
- ALINITY H-SERIES PHOSPHATE BUFFER
- ALINITY H-SERIES RETIC REAGENT
- ALINITY H-SERIES SMEAR FIX
- ALINITY H-SERIES WBC REAGENT
- ALINITY H-SERIES WRIGHT-GIEMSA STAIN
- 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.