Medical device licence · 95310 · Class 3
PRECISE TYPE HEA MOLECULAR BEADCHIP TEST
Yes: licensed in Canada
Licence status Issued (active); first licensed June 23, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95310
- Licence holder
- Bioarray Solutions Ltd.Warren, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 23, 2015
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PRECISE TYPE BEADCHIP TEST/HEA
- PRECISE TYPE HEA BEADCHECK KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.