Medical device licence · 109335 · Class 3
SOFIA STREP A+ FIA
Yes: licensed in Canada
Licence status Issued (active); first licensed May 15, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109335
- Licence holder
- Ortho-Clinical Diagnostics, Inc.Athens, OH, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- May 15, 2023
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SOFIA STREP A+ FIA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.