Medical device licence · 95748 · Class 3
ID NOW
Yes: licensed in Canada
Licence status Issued (active); first licensed September 15, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95748
- Licence holder
- Abbott Diagnostics Scarborough, Inc.Scarborough, ME, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 15, 2015
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ID NOW INFLUENZA A & B 2
- ID NOW INFLUENZA A & B 2 CONTROL SWAB KIT
- ID NOW INSTRUMENT
- ID NOW RSV
- ID NOW RSV CONTROL SWAB KIT
- ID NOW STREP A 2
- ID NOW STREP A 2 CONTROL SWAB KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.