BIOFIRE DIAGNOSTICS, LLC

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

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Filters

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) (3)

Premarket Exempt

No Yes

Clear

FilmArray® 2.0 Instrument - 00815381029058 Catalog Number :

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® Torch System Base - 00815381029072 Catalog Number :

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 - 00815381029089 Catalog Number :

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

Device Class : 2

Duns Number: 079280262

Premarket Exempt : No

Product Code : NSU

Prescription Use : No

Device Count : 1

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