Medical device licence · 76844 · Class 3
HER-2/NEU ELISA
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed April 17, 2008; ended October 31, 2016. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 76844
- Licence holder
- Nuclea Diagnostic Laboratories, Llc.Cambridge, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- April 17, 2008
- Ended
- October 31, 2016
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HER-2/NEU ELISA ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.