Medical device licence · 108103 · Class 2
IMMUNOCAP TOTAL IGE
Yes: licensed in Canada
Licence status Issued (active); first licensed August 3, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108103
- Licence holder
- Phadia AbUppsala, Sweden
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- August 3, 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 TOTAL IGE ANTI-IGE
- IMMUNOCAP TOTAL IGE CALIBRATOR STRIP
- IMMUNOCAP TOTAL IGE CONJUGATE
- IMMUNOCAP TOTAL IGE CONTROL LMH
- IMMUNOCAP TOTAL IGE CURVE CONTROL STRIP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.