Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1249288440
Device Listing 1249288440
Listing Summary
#
Listing key
1249288440
Premarket submission
K230404
Device
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Applicant
Biofire Diagnostics, LLC
Product code
PCH
Decision date
2023-03-16
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
175756
3002773840
3002773840
BioFire Diagnostics, LLC
1
N
2026-01-01
515 Colorow Drive Salt Lake City UT US 84108