Medical device licence · 88752 · Class 3
SMART HBA1C SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed April 27, 2012; ended September 22, 2022. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 88752
- Licence holder
- Diazyme Laboratories Inc.Poway, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 27, 2012
- Ended
- September 22, 2022
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SMART DIRECT HBA1C ANALYZER
- SMART HBA1C ASSAY CONTROL SET
- SMART HBA1C ASSAY REAGENT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.