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Company-Registration
1822931117
Device Listing 1822931117
Listing Summary
#
Listing key
1822931117
Premarket submission
K243463
Device
BIOFIRE FILMARRAY Tropical Fever Panel
Applicant
Biofire Diagnostics, LLC (Biomerieux)
Product code
QMV
Decision date
2024-12-05
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
175758
3010770794
3010770794
BioFire Defense, LLC
1
N
2026-01-01
79 W 4500 S Ste 14 Salt Lake City UT US 84107