ApprovalTrail

Medical device licence · 96037 · Class 3

FILMARRAY RESPIRATORY PANEL

No longer licensed: cancelled

Licence status Cancelled; first licensed November 9, 2015; ended December 20, 2023. It is in Health Canada’s archive of licences no longer in force.
Licence number
96037
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
November 9, 2015
Ended
December 20, 2023
Devices covered
1

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • FILMARRAY RESPIRATORY PANEL

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.

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.