BIOFIRE DIAGNOSTICS, LLC

Address:515 Colorow Drive,Salt Lake City,UT,84108,US

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Device Class
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Premarket Exempt
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- 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

- 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

- 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

- 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

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

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

- 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

- 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

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

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