BioFire® Respiratory Panel 2.1

GUDID 00815381020529

IVD reagent kit containing 30 tests.

BIOFIRE DIAGNOSTICS, LLC

Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00815381020529
NIH Device Record Keye2b3cbad-bacc-4502-a2c5-1240b0b756f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioFire® Respiratory Panel 2.1
Version Model Number423742
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
GS100815381020529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-21
Device Publish Date2021-04-13

Devices Manufactured by BIOFIRE DIAGNOSTICS, LLC

00815381020727 - BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini2024-08-05 IVD reagent kit containing 30 tests.
00815381020390 - BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel2024-05-13 IVD reagent kit containing 30 tests.
00815381020765 - BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini2023-05-17 IVD reagent kit containing 30 tests.
00815381020055 - BIOFIRE ® SPOTFIRE ® Control Station2023-04-14 IVD Instrument (SPOTFIRE ® Control Station).
00815381020352 - BIOFIRE ® SPOTFIRE ® Control Station2023-04-14 Used IVD Instrument (SPOTFIRE® Control Station).
00815381020369 - BIOFIRE ® SPOTFIRE ® Module2023-04-14 IVD Instrument (SPOTFIRE ® Module).
00815381020376 - BIOFIRE ® SPOTFIRE ® Module2023-04-14 Used IVD Instrument (SPOTFIRE® Module).
00815381020659 - BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel2023-04-14 IVD reagent kit containing 30 tests.

Trademark Results [BioFire]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOFIRE
BIOFIRE
97123037 not registered Live/Pending
Biofire Technologies Inc.
2021-11-12
BIOFIRE
BIOFIRE
88852597 not registered Live/Pending
Biofire Technologies Inc.
2020-03-30
BIOFIRE
BIOFIRE
87204256 not registered Live/Pending
Biofire Technologies Inc.
2016-10-14
BIOFIRE
BIOFIRE
85981790 4534857 Live/Registered
Idaho Technology, Inc.
2012-08-09
BIOFIRE
BIOFIRE
79057952 3722496 Live/Registered
CONCEPT Gesellschaft für kreative; Produktentwicklung Gesellschaft m.b.H.
2008-07-11

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