Medical device licence · 108818 · Class 2
IMMUNOCAP SPECIFIC IGE
Yes: licensed in Canada
Licence status Issued (active); first licensed January 31, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 108818
- Licence holder
- Phadia AbUppsala, Sweden
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- January 31, 2023
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMMUNOCAP IGE/ECP/TRYPTASE SAMPLE DILUENT
- IMMUNOCAP SPECIFIC IGE ANTI-IGE
- IMMUNOCAP SPECIFIC IGE CALIBRATOR STRIP
- IMMUNOCAP SPECIFIC IGE CONJUGATE
- IMMUNOCAP SPECIFIC IGE CONTROL H
- IMMUNOCAP SPECIFIC IGE CONTROL L
- IMMUNOCAP SPECIFIC IGE CONTROL M
- IMMUNOCAP SPECIFIC IGE CURVE CONTROL
- IMMUNOCAP SPECIFIC IGE NEGATIVE CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.