BIOFIRE DIAGNOSTICS, LLC

BIOFIRE DIAGNOSTICS, LLC

Address:515 Colorow Drive,Salt Lake City,UT,84108,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) (4) Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System (PCH) (2) Gram-Negative Bacteria And Associated Resistance Markers (PEN) (2) Gram-Positive Bacteria And Their Resistance Markers (PAM) (2) Human Metapneumovirus (Hmpv) Rna Assay System (OEM) (2) Influenza A Virus Subtype Differentiation Nucleic Acid Assay (OEP) (2) Mycoplasma Pneumoniae Dna Assay System (OZX) (2) Non-Sars Coronavirus Multiplex Nucleic Acid Assay (OTG) (2) Parainfluenza Multiplex Nucleic Acid Assay (OOU) (2) Real Time Nucleic Acid Amplification System (OOI) (2) Bordetella Pertussis Dna Assay System (OZZ) (2) Respiratory Virus Panel Nucleic Acid Assay System (OCC) (2)

Premarket Exempt

No Yes

Clear

FilmArray® Instrument - 00815381020017 Catalog Number : FLM1-ASY-0001

Device Description : IVD Instrument (FilmArray® Instrument)

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : NSU

Prescription Use : No

Device Count : 1

FilmArray® Instrument - 00815381020024 Catalog Number : FLM1-ASY-0001R

Device Description : Refurbished IVD Instrument (FilmArray® Instrument).

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : NSU

Prescription Use : No

Device Count : 1

FilmArray® 2.0 Instrument - 00815381020031 Catalog Number : FLM2-ASY-0001

Device Description : IVD Instrument (FilmArray® 2.0 Instrument).

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : NSU

Prescription Use : No

Device Count : 1

FilmArray® 2.0 Instrument - 00815381020048 Catalog Number : FLM2-ASY-0001R

Device Description : Refurbished IVD Instrument (FilmArray® 2.0 Instrument).

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : NSU

Prescription Use : No

Device Count : 1

FilmArray® Respiratory Panel (RP) - 00815381020062 Catalog Number : RFIT-ASY-0124

Device Description : IVD reagent kit containing 30 tests.

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : OEM, OZX, OZZ, OTG, OEP, OOU, OCC

Prescription Use : Yes

Device Count : 1

FilmArray® Respiratory Panel (RP) - 00815381020079 Catalog Number : RFIT-ASY-0125

Device Description : IVD reagent kit containing 6 tests.

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : OCC, OOU, OEP, OTG, OZZ, OZX, OEM

Prescription Use : Yes

Device Count : 1

FilmArray® BCID Panel - 00815381020086 Catalog Number : RFIT-ASY-0126

Device Description : IVD reagent kit containing 30 tests.

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : OOI, PAM, PEN

Prescription Use : Yes

Device Count : 1

FilmArray® BCID Panel - 00815381020093 Catalog Number : RFIT-ASY-0127

Device Description : IVD reagent kit containing 6 tests.

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : OOI, PAM, PEN

Prescription Use : Yes

Device Count : 1

FilmArray® Gastrointestinal (GI) Panel - 00815381020109 Catalog Number : RFIT-ASY-0116

Device Description : IVD reagent kit containing 30 tests.

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : PCH

Prescription Use : Yes

Device Count : 1

FilmArray® Gastrointestinal (GI) Panel - 00815381020116 Catalog Number : RFIT-ASY-0104

Device Description : IVD reagent kit containing 6 tests.

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : PCH

Prescription Use : Yes

Device Count : 1

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