Medical device licence · 104637 · Class 2
ACCESS C-PEPTIDE
Yes: licensed in Canada
Licence status Issued (active); first licensed May 9, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104637
- Licence holder
- Beckman Coulter, Inc.San Diego, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- May 9, 2020
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCESS C-PEPTIDE
- ACCESS C-PEPTIDE CALIBRATORS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.