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BioFire Defense, LLC

Last updated September 17, 2026

Information

Country: US
Address: 79 W 4500 S Ste 14, Salt Lake City, UT, 84107
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3010770794
DUNS Number: —

Catalogue (33)

Device	Model / Reference	Registries	Class	Status
Filmarray® Commercial Laptop	COMP-SUB-0034	FDA UDI	Class II	Active
Jbaids	JRPD-ASY-0016	FDA UDI	Class I	Unknown
FilmArray® 2.0 Instrument NGDS Configuration	NGDS-ASY-0002	FDA UDI	Class II	Active
BioFire® COVID-19 Test 2	DFA2-ASY-0016	FDA UDI	Class II	Active
Jbaids	JRPD-ASY-0123	FDA UDI	U	Unknown
Jbaids	JRPD-ASY-0138	FDA UDI	Class II	Unknown
BioFire® Global Fever Panel	DFA2-ASY-0004	FDA UDI	Class II	Active
Jbaids	JB01	FDA UDI	Class II	Unknown
Filmarray Ngds Warrior Panel - Ca	DFA2-ASY-0012	FDA UDI	N/A	Active
Filmarray	1.5	FDA UDI	Class II	Unknown
FilmArray® 2.0 Instrument NGDS Configuration	NGDS-ASY-0002	FDA UDI	Class II	Active
Ngds	NGDS-ASY-0006	FDA UDI	Class II	Unknown
BioFire® Global Fever Special Pathogens Panel	DFA2-ASY-0018	FDA UDI	Class II	Active
BioFire® COVID-19 Test 2	DFA2-ASY-0015	FDA UDI	Class II	Active
Jbaids	JRPD-ASY-0137	FDA UDI	Class II	Unknown
BioFire Warrior Panel Control Kit	DFA2-ASY-0047	FDA UDI	Class II	Active
BioFire Warrior Panel	NGDS-ASY-0018	FDA UDI	N/A	Active
Jbaids	JRPD-ASY-0136	FDA UDI	Class II	Unknown
Jbaids	JRPD-ASY-0124	FDA UDI	Class II	Unknown
FilmArray® NGDS Warrior Panel	NGDS-ASY-0007	FDA UDI	N/A	Active
Jbaids	JRPD-ASY-0116	FDA UDI	Class II	Unknown
FilmArray® 2.0 Instrument NGDS Configuration	NGDS-ASY-0004	FDA UDI	Class II	Active
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane	DFA2-ASY-0019	FDA UDI	Class II	Active
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel	DFA2-ASY-0006	FDA UDI	Class II	Active
FilmArray NGDS Warrior Panel	K170883	FDA 510(k)	N/A	Active
BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel	K213362	FDA 510(k)	Class II	Active
FilmArray Global Fever Panel	DEN200043	FDA 510(k)	Class II	Active
BioFire COVID-19 Test 2	K211079	FDA 510(k)	Class II	Active
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel	K220870	FDA 510(k)	Class II	Active
FilmArray Global Fever Panel External Control Kit	K202382	FDA 510(k)	Class II	Active
BioFire Warrior Panel; BioFire Warrior Panel Control Kit	K243822	FDA 510(k)	N/A	Active
FilmArray NGDS Warrior Panel	DEN160048	FDA 510(k)	N/A	Active
BioFire COVID-19 Test 2	K221460	FDA 510(k)	Class II	Active

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 10, 2025	Z-2609-2025	—	open, classified	FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
Aug 20, 2019	Z-1448-2020	—	terminated	The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.
Aug 13, 2014	Z-2644-2014	—	terminated	BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because the wrong version software may have been installed.