BIOFIRE ® SPOTFIRE ® Control Station

GUDID 00815381020055

IVD Instrument (SPOTFIRE ® Control Station).

BIOFIRE DIAGNOSTICS, LLC

Thermal cycler nucleic acid amplification analyser IVD, laboratory
Primary Device ID00815381020055
NIH Device Record Keyf8ddcabc-c242-4376-ba87-e726d87d9295
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOFIRE ® SPOTFIRE ® Control Station
Version Model NumberFAST-ASY-0001
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815381020055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NSUInstrumentation For Clinical Multiplex Test Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-14
Device Publish Date2023-04-06

On-Brand Devices [BIOFIRE ® SPOTFIRE ® Control Station]

00815381020352Used IVD Instrument (SPOTFIRE® Control Station).
00815381020055IVD Instrument (SPOTFIRE ® Control Station).

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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