Medical device licence · 60375 · Class 3
ONESTEP STREP A TEST
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed August 29, 2002; ended December 11, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 60375
- Licence holder
- Syntron Bioresearch IncCarlsbad, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- August 29, 2002
- Ended
- December 11, 2019
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- QUIKPAC STREP A TEST
- QUIKSTRIP STREP A TEST
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.