Medical device licence · 114353 · Class 4
ACCESS SYPHILIS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 21, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 114353
- Licence holder
- Beckman Coulter, Inc.San Diego, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Test Kit
- First licensed
- November 21, 2025
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCESS SYPHILIS
- ACCESS SYPHILIS CALIBRATORS
- ACCESS SYPHILIS QC
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.