Medical device licence · 116345 · Class 2
C-PEPTIDE ELISA
Yes: licensed in Canada
Licence status Issued (active); first licensed October 7, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 116345
- Licence holder
- Diagnostics Biochem Canada Inc.London, ON, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- October 7, 2026
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- C-PEPTIDE ELISA
- C-PEPTIDE ELISA CALIBRATOR A
- C-PEPTIDE ELISA CALIBRATOR B
- C-PEPTIDE ELISA CALIBRATOR C
- C-PEPTIDE ELISA CALIBRATOR D
- C-PEPTIDE ELISA CALIBRATOR E
- C-PEPTIDE ELISA CALIBRATOR F
- C-PEPTIDE ELISA CONTROL 1
- C-PEPTIDE ELISA CONTROL 2
- C-PEPTIDE ELISA HRP CONJUGATE
- C-PEPTIDE ELISA MICROPLATE
- C-PEPTIDE ELISA STOPPING SOLUTION
- C-PEPTIDE ELISA TMB SUBSTRATE
- C-PEPTIDE ELISA WASH BUFFER CONCENTRATE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.