FilmArray® Respiratory Panel 2 (RP2) RFIT-ASY-0130

GUDID 00815381020161

IVD reagent kit containing 6 tests

BIOFIRE DIAGNOSTICS, LLC

Multiple respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00815381020161
NIH Device Record Key274c8e71-d3b2-4bb5-8469-50b7d089d26e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFilmArray® Respiratory Panel 2 (RP2)
Version Model NumberRFIT-ASY-0130
Catalog NumberRFIT-ASY-0130
Company DUNS079280262
Company NameBIOFIRE DIAGNOSTICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815381020161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZZBordetella Pertussis Dna Assay System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-07-18

On-Brand Devices [FilmArray® Respiratory Panel 2 (RP2)]

00815381020161IVD reagent kit containing 6 tests
00815381020154IVD reagent kit containing 30 tests

Trademark Results [FilmArray]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FILMARRAY
FILMARRAY
85939258 4554601 Live/Registered
BioFire Diagnostics, Inc.
2013-05-22
FILMARRAY
FILMARRAY
77083897 3761522 Live/Registered
BIOFIRE DIAGNOSTICS, LLC
2007-01-16

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