Medical device licence · 91007 · Class 2
LYRA RSV+HMPV ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed April 3, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91007
- Licence holder
- Ortho-Clinical Diagnostics, Inc.Athens, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- April 3, 2013
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LYRA RSV+HMPV ASSAY
- QUIDEL MOLECULAR RSV+HMPV CONTROL SET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.