Medical device licence · 94812 · Class 2
ONSITE FOB RAPID TEST
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed March 3, 2015; ended October 31, 2018. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 94812
- Licence holder
- Ctk Biotech, Inc.San Diego, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- March 3, 2015
- Ended
- October 31, 2018
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ONSITE FOB RAPID TEST KIT
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “onsite”. A notice may cover another product or only some lots: read it to see what it covers.
- HeartStart HS1 Home, HS1 OnSite, FRx or FR2/FR2+ AED (2021-03-03)March 18, 2021 · Medical devices · Medical devices · Type II
- Philips HeartStart OnSite and Home Defibrillator and HeartStart FRx Automated External Defibrillator (2018-02-23)March 13, 2018 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.