Medical device licence · 108116 · Class 2
IMMUNOCAP TRYPTASE
Yes: licensed in Canada
Licence status Issued (active); first licensed August 5, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108116
- Licence holder
- Phadia AbUppsala, Sweden
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- August 5, 2022
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMMUNOCAP IGE / ECP/TRYPTASE DILUENT
- IMMUNOCAP TRYPTASE ANTI-TRYPTASE
- IMMUNOCAP TRYPTASE CALIBRATOR STRIP
- IMMUNOCAP TRYPTASE CONJUGATE
- IMMUNOCAP TRYPTASE CONTROL
- IMMUNOCAP TRYPTASE CURVE CONTROL STRIP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.