Medical device licence · 103389 · Class 2
ASPERGILLUS ANTIGEN ELISA
Yes: licensed in Canada
Licence status Issued (active); first licensed August 1, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103389
- Licence holder
- Euroimmun Medizinische Labordiagnostika AgLubeck, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- August 1, 2019
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ASPERGILLUS ANTIGEN ELISA
- BIOTIN (ASPERGILLUS ANTIGEN), READY FOR USE
- ENZYME CONJUGATE (ASPERGILLUS ANTIGEN), READY FOR USE
- SAMPLE BUFFER FOR ASPERGILLUS ANTIGEN ELISA, READY FOR USE
- STOP SOLUTION
- SUBSTRATE
- WASH BUFFER, 10X CONCENTRATED
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.