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) (5) Real Time Nucleic Acid Amplification System (OOI) (2) Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System (PZF) (2) Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System (QDS) (2) Fungal Organisms, Nucleic Acid-Based Assay (PEO) (1) Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents (QOF) (1) Gram-Positive Bacteria And Their Resistance Markers (PAM) (1) Reagents, 2019-Novel Coronavirus Nucleic Acid (QJR) (1)

Premarket Exempt

No Yes

Clear

FilmArray® Torch System Base - 00815381020260 Catalog Number : HTFA-ASY-0104R

Device Description : Refurbished IVD Instrument (FilmArray® Torch System Base).

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : NSU

Prescription Use : No

Device Count : 1

FilmArray® Torch Module - 00815381020277 Catalog Number : HTFA-SUB-0103

Device Description : IVD Instrument (FilmArray® Torch Module).

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : NSU

Prescription Use : No

Device Count : 1

FilmArray® Torch Module - 00815381020284 Catalog Number : HTFA-SUB-0103R

Device Description : Refurbished IVD instrument (Torch Module)

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : NSU

Prescription Use : No

Device Count : 1

FilmArray® Respiratory Panel 2 plus (RP2plus) - 00815381020291 Catalog Number : RFIT-ASY-0136

Device Description : IVD reagent kit containing 30 tests

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : NSU, OOI, PZF

Prescription Use : Yes

Device Count : 1

FilmArray® Respiratory Panel 2 plus (RP2plus) - 00815381020307 Catalog Number : RFIT-ASY-0137

Device Description : IVD reagent kit containing 6 tests

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : OOI, NSU, PZF

Prescription Use : Yes

Device Count : 1

FilmArray® Pneumonia Panel plus (Pneumoplus) - 00815381020314 Catalog Number :

Device Description : IVD reagent kit containing 30 tests

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : QDS

Prescription Use : Yes

Device Count : 1

FilmArray® Pneumonia Panel plus (Pneumoplus) - 00815381020321 Catalog Number :

Device Description : IVD reagent kit containing 6 tests

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : QDS

Prescription Use : Yes

Device Count : 1

BioFire® Blood Culture Identification 2 (BCID2) Panel - 00815381020338 Catalog Number :

Device Description : IVD reagent kit containing 30 tests.

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : PAM, PEO

Prescription Use : Yes

Device Count : 1

BioFire® Respiratory Panel 2.1 EUA - 00815381020482 Catalog Number :

Device Description : IVD reagent kit containing 30 tests.

Device Class :

Duns Number: 079280262

Premarket Exempt : Yes

Product Code : QJR

Prescription Use : Yes

Device Count : 1

BioFire® Respiratory Panel 2.1 - 00815381020529 Catalog Number :

Device Description : IVD reagent kit containing 30 tests.

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : QOF

Prescription Use : Yes

Device Count : 1

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