Medical device licence · 82570 · Class 2
MALARIA (MAL) ANTIGEN TEST DEVICE
Yes: licensed in Canada
Licence status Issued (active); first licensed April 15, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82570
- Licence holder
- Artron Laboratories Inc.Burnaby, BC, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- April 15, 2010
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MALARIA (PF) ANTIGEN TEST DEVICE (CASSETTE FORMAT)
- MALARIA (PF/PV) ANTIGEN TEST DEVICE (CASSETTE FORMAT)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.