BIOFIRE DIAGNOSTICS, LLC

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

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- Catalog Number : RFIT-ASY-0118

Device Description : IVD reagent kit containing 30 tests.

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : PLO

Prescription Use : Yes

Device Count : 1

- Catalog Number : RFIT-ASY-0119

Device Description : IVD reagent kit containing 6 tests.

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : PLO

Prescription Use : Yes

Device Count : 1

- Catalog Number : RFIT-ASY-0120

Device Description : IVD reagent kit containing 30 tests.

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : OZX, OZY, OZZ, OOI, OQW, OTG, OEP, OOU, OEM, OCC

Prescription Use : Yes

Device Count : 1

- Catalog Number : RFIT-ASY-0129

Device Description : IVD reagent kit containing 30 tests

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

- Catalog Number : RFIT-ASY-0130

Device Description : IVD reagent kit containing 6 tests

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : IVD reagent kit containing 30 tests

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : QBH

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : IVD reagent kit containing 6 tests

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : QBH

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : IVD reagent kit containing 30 kits.

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : QSN

Prescription Use : Yes

Device Count : 1

- 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

- Catalog Number : HTFA-ASY-0104

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

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : NSU

Prescription Use : No

Device Count : 1