JBAIDS JRPD-ASY-0001

GUDID 00851458005006

JBAIDS Instrument

BIOFIRE DEFENSE, LLC

Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Primary Device ID00851458005006
NIH Device Record Key29ffced7-fc8b-4da4-b666-9deec3855b0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameJBAIDS
Version Model NumberJB01
Catalog NumberJRPD-ASY-0001
Company DUNS556915205
Company NameBIOFIRE DEFENSE, 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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851458005006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHTAssay, Nucleic Acid Amplification, Bacillus Anthracis

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 Date2016-09-07

On-Brand Devices [JBAIDS]

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00851458005075JBAIDS IVD Influenza A Subtyping Kit
00851458005068JBAIDS IVD Influenza A & B Detection Kit
00851458005044JBAIDS IVD Plague Detection Kit
00851458005037JBAIDS IVD Anthrax Detection Kit
00851458005020JBAIDS IVD Tularemia Detection Kit
00851458005013JBAIDS IVD Q Fever Detection Kit
00851458005006JBAIDS Instrument

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