BIOFIRE DEFENSE, LLC

BIOFIRE DEFENSE, LLC

Address:79 W 4500 S Ste 14,Salt Lake City,UT,84107,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Instrumentation For Clinical Multiplex Test Systems (NSU) (2) Assay, Nucleic Acid Amplification, Bacillus Anthracis (NHT) (2) Biothreat Microbial Agents Multiplex Nucleic Acid Detection System (PRD) (1) Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit (OEH) (1) Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna (NXD) (1) Real Time Nucleic Acid Amplification System (OOI) (1) Respiratory Virus Panel Nucleic Acid Assay System (OCC) (1) 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification (OQW) (1) Yersinia Spp. Reagents (OIH) (1) Assay, Direct, Nucleic Acid Amplification, Q Fever (OVF) (1)

Premarket Exempt

No

Clear

JBAIDS - 00851458005006 Catalog Number : JRPD-ASY-0001

Device Description : JBAIDS Instrument

Device Class : 2

Duns Number: 556915205

Premarket Exempt : No

Product Code : NHT

Prescription Use : No

Device Count : 1

JBAIDS - 00851458005013 Catalog Number : JRPD-ASY-0016

Device Description : JBAIDS IVD Q Fever Detection Kit

Device Class : 1

Duns Number: 556915205

Premarket Exempt : No

Product Code : OVF

Prescription Use : Yes

Device Count : 1

JBAIDS - 00851458005020 Catalog Number : JRPD-ASY-0124

Device Description : JBAIDS IVD Tularemia Detection Kit

Device Class : 2

Duns Number: 556915205

Premarket Exempt : No

Product Code : OEH

Prescription Use : Yes

Device Count : 1

JBAIDS - 00851458005037 Catalog Number : JRPD-ASY-0116

Device Description : JBAIDS IVD Anthrax Detection Kit

Device Class : 2

Duns Number: 556915205

Premarket Exempt : No

Product Code : NHT

Prescription Use : Yes

Device Count : 1

JBAIDS - 00851458005044 Catalog Number : JRPD-ASY-0123

Device Description : JBAIDS IVD Plague Detection Kit

Device Class : U

Duns Number: 556915205

Premarket Exempt : No

Product Code : OIH

Prescription Use : Yes

Device Count : 1

FilmArray® 2.0 Instrument NGDS Configuration - 00851458005051 Catalog Number : NGDS-ASY-0002

Device Description : IVD Instrument NGDS Configuration.

Device Class : 2

Duns Number: 556915205

Premarket Exempt : No

Product Code : NSU

Prescription Use : No

Device Count : 1

JBAIDS - 00851458005068 Catalog Number : JRPD-ASY-0137

Device Description : JBAIDS IVD Influenza A & B Detection Kit

Device Class : 2

Duns Number: 556915205

Premarket Exempt : No

Product Code : OCC

Prescription Use : Yes

Device Count : 1

JBAIDS - 00851458005075 Catalog Number : JRPD-ASY-0138

Device Description : JBAIDS IVD Influenza A Subtyping Kit

Device Class : 2

Duns Number: 556915205

Premarket Exempt : No

Product Code : OQW

Prescription Use : Yes

Device Count : 1

JBAIDS - 00851458005082 Catalog Number : JRPD-ASY-0136

Device Description : JBAIDS IVD Influenza A/H5 Detection Kit

Device Class : 2

Duns Number: 556915205

Premarket Exempt : No

Product Code : NXD

Prescription Use : Yes

Device Count : 1

NGDS - 00851458005099 Catalog Number : NGDS-ASY-0006

Device Description : FilmArray® NGDS Warrior Panel - IVD reagent Biothreat Detection Kit containing 30 tests.

Device Class : 2

Duns Number: 556915205

Premarket Exempt : No

Product Code : NSU, OOI, PRD

Prescription Use : No

Device Count : 1

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