Medical device licence · 111826 · Class 3
FILMARRAY PNEUMONIA PANEL PLUS
Yes: licensed in Canada
Licence status Issued (active); first licensed September 20, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111826
- Licence holder
- Biofire Diagnostics, Llc.Salt Lake City, UT, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- September 20, 2024
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FILMARRAY PNEUMONIA PANEL PLUS
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “filmarray”. A notice may cover another product or only some lots: read it to see what it covers.
- FilmArray® NGDS Warrior PanelAugust 5, 2026 · Microbiology · Performance · Type II
- BioFire® FilmArray® Pneumonia (PNplus) Panel PlusAugust 15, 2025 · Microbiology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.