ApprovalTrail

Medical device licence · 96211 · Class 3

FILMARRAY SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed December 9, 2015. It is in Health Canada’s list of active licences.
Licence number
96211
Licence holder
Biofire Diagnostics, Llc.Salt Lake City, UT, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
December 9, 2015
Devices covered
2

Devices on this licence

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

  • FILMARRAY 2.0
  • FILMARRAY INSTRUMENT

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.