Medical device licence · 102445 · Class 2
IDK BIOTIN ELISA
Yes: licensed in Canada
Licence status Issued (active); first licensed February 20, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102445
- Licence holder
- Immundiagnostik AgBensheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- February 20, 2019
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELISA STOP
- ELISA SUB
- ELISA WASHBUF
- IDK BIOTIN ELISA
- IDK BIOTIN ELISA CONJ
- IDK BIOTIN ELISA CTRL
- IDK BIOTIN ELISA PLATE
- IDK BIOTIN ELISA STDS
- IDK BIOTIN SAMPLEBUF
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.