Medical device licence · 102703 · Class 3
ABBOTT REALTIME IDH2
Yes: licensed in Canada
Licence status Issued (active); first licensed April 11, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102703
- Licence holder
- Abbott Molecular Inc.Des Plaines, IL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- April 11, 2019
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ABBOTT REALTIME IDH2 AMPLIFICATION REAGENT KIT
- ABBOTT REALTIME IDH2 CONTROL KIT
- ABBOTT REALTIME IDH2 M2000RT APPLICATION CD-ROM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.