Medical device licence · 87719 · Class 3
OSOM STREP A TEST
Yes: licensed in Canada
Licence status Issued (active); first licensed December 2, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 87719
- Licence holder
- Sekisui Diagnostics, LlcLexington, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- December 2, 2011
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OSOM STREP A TEST KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.