Medical device licence · 83651 · Class 3
QUIKCOAG APTT-EA
Yes: licensed in Canada
Licence status Issued (active); first licensed August 18, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 83651
- Licence holder
- Biomedica Diagnostics Inc.Stamford, CT, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- August 18, 2010
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- QUIKCOAG APTT BULK
- QUIKCOAG APTT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.