Medical device licence · 109396 · Class 2
IMMUNOCAP SPECIFIC IGG4
Yes: licensed in Canada
Licence status Issued (active); first licensed May 29, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109396
- Licence holder
- Phadia AbUppsala, Sweden
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- May 29, 2023
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMMUNOCAP IGA/IGG CALIBRATOR IMMUNOCAP
- IMMUNOCAP SPECIFIC IGA/IGG SAMPLE DILUENT
- IMMUNOCAP SPECIFIC IGG SAMPLE DILUENT
- IMMUNOCAP SPECIFIC IGG/IGG4 CONTROL L
- IMMUNOCAP SPECIFIC IGG/IGG4 I1 CONTROL H
- IMMUNOCAP SPECIFIC IGG4 CALIBRATOR STRIP
- IMMUNOCAP SPECIFIC IGG4 CONJUGATE 50
- IMMUNOCAP SPECIFIC IGG4 CURVECONTROL STRIP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.