Medical device licence · 102169 · Class 2
IIFT MOSAIC: BASIC PROFILE 2 EUROPATTERN
Yes: licensed in Canada
Licence status Issued (active); first licensed December 13, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 102169
- Licence holder
- Euroimmun Medizinische Labordiagnostika AgLubeck, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- December 13, 2018
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IIFT MOSAIC: BASIC PROFILE 2 EUROPATTERN
- POSITIVE CONTROL (IIFT): ANTIBODIES AGAINST CELL NUCLEI (ANA CONTROL), HOMOGENEOUS PATTERN
- POSITIVE CONTROL (IIFT): ANTIBODIES AGAINST MITOCHONDRIA (AMA M2 CONTROL; ASSOCIATED WITH PBC)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.