Medical device licence · 98924 · Class 3
ABBOTT REALTIME EBV
Yes: licensed in Canada
Licence status Issued (active); first licensed April 7, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98924
- Licence holder
- Abbott Molecular Inc.Des Plaines, IL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 7, 2017
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ABBOTT REALTIME EBV
- ABBOTT REALTIME EBV AMPLIFICATION REAGENT KIT
- ABBOTT REALTIME EBV CALIBRATOR KIT
- ABBOTT REALTIME EBV CONTROL KIT
- ABBOTT REALTIME EBV M2000 SYSTEM ROW COMBINED APPLICATION CD-ROM, VERSION 2.0
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.