ApprovalTrail

Company · Salt Lake City, UT, United States

Biofire Diagnostics, Llc.

Everything this company holds in Health Canada’s product databases, as the company’s name is spelled there.

Drug products (DIN)
0
0 authorized now
Natural health products
0
0 active licences
Medical device licences
11
8 active
Notices of Compliance
0

Medical device licences

Active licences first, newest first.

NameLicenceStatus
BIOFIRE RESPIRATORY PANEL (RP2.1)116036Issued (active) · Class 2
FILMARRAY PNEUMONIA PANEL PLUS111826Issued (active) · Class 3
BIOFIRE JOINT INFECTION (JI) PANEL109934Issued (active) · Class 3
BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL107734Issued (active) · Class 3
FILMARRAY TORCH102421Issued (active) · Class 3
FILMARRAY MENINGITIS / ENCEPHALITIS (ME) PANEL97610Issued (active) · Class 3
FILMARRAY SYSTEM96211Issued (active) · Class 3
FILMARRAY GASTROINTESTINAL (GI) PANEL95822Issued (active) · Class 3
FILMARRAY RESPIRATORY PANEL 2 PLUS (RP2PLUS)104611Cancelled · Class 3
FILMARRAY RESPIRATORY PANEL96037Cancelled · Class 3
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL96019Cancelled · Class 3

Recalls and safety alerts that mention its products

Health Canada’s recall notices do not carry licence numbers, so these are matched by name. A notice may cover another product or only some lots: read it to see what it covers.