Medical device licence · 113032 · Class 2
TESTO FASTPACK REAGENT KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed April 3, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113032
- Licence holder
- Qualigen Inc.Carlsbad, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- April 3, 2025
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TESTO CALIBRATOR KIT
- TESTO FASTPACK REAGENT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.