Medical device licence · 102569 · Class 3
RAPID RESPONSE HEMOGLOBIN A1C ANALYZER
Yes: licensed in Canada
Licence status Issued (active); first licensed March 14, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102569
- Licence holder
- Btnx Inc.Pickering, ON, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 14, 2019
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- RAPID RESPONSE HEMOGLOBIN A1C ANALYZER
- RAPID RESPONSE HEMOGLOBIN A1C CONTROL SOLUTIONS
- RAPID RESPONSE HEMOGLOBIN A1C REAGENT CARTRIDGE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.