Medical device licence · 35456 · Class 3
OSOM ULTRA STREP A
Yes: licensed in Canada
Licence status Issued (active); first licensed January 10, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 35456
- Licence holder
- Sekisui Diagnostics, LlcLexington, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- January 10, 2002
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OSOM ULTRA STREP A TEST
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.