Medical device licence · 109397 · Class 2
IMMUNOCAP SPECIFIC IGG
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
- 109397
- Licence holder
- Phadia AbUppsala, Sweden
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- May 29, 2023
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMMUNOCAP ANTIGEN GE90, BUDGERIGAR SERUM PROTEINS, FEATHERS AND DROPPINGS
- IMMUNOCAP ANTIGEN GE91, PIGEON SERUM PROTEINS, FEATHERS AND DROPPINGS
- IMMUNOCAP ANTIGEN GE92, PARROT SERUM PROTEINS, FEATHERS AND DROPPINGS
- IMMUNOCAP ANTIGEN GE93, PIGEON SERUM PROTEINS
- IMMUNOCAP ANTIGEN GM22, MICROPOLYSPORA FAENI
- IMMUNOCAP ANTIGEN GM24, STACHYBOTRYS ATRA
- IMMUNOCAP ANTIGEN GM42, LACEYELLA SACCHARI
- IMMUNOCAP IGA/IGG CALIBRATOR IMMUNOCAP
- IMMUNOCAP SPECIFIC IGA/IGG SAMPLE DILUENT
- IMMUNOCAP SPECIFIC IGG CALIBRATOR STRIP
- IMMUNOCAP SPECIFIC IGG CONJUGATE 50
- IMMUNOCAP SPECIFIC IGG CURVECONTROL STRIP
- IMMUNOCAP SPECIFIC IGG M3 CONTROL H
- IMMUNOCAP SPECIFIC IGG SAMPLE DILUENT
- IMMUNOCAP SPECIFIC IGG/IGG4 CONTROL L
- IMMUNOCAP SPECIFIC IGG/IGG4 I1 CONTROL H
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.