FDA.reportPublic FDA data

JBAIDS

Primary DI
00851458005006
Brand
JBAIDS
Company
BIOFIRE DEFENSE, LLC
Model
JB01
Catalog number
JRPD-ASY-0001
Device description
JBAIDS Instrument
Published
2016-09-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHTAssay, Nucleic Acid Amplification, Bacillus Anthracis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHTAssay, Nucleic Acid Amplification, Bacillus AnthracisMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051713000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051713000JBAIDS ANTHRAC DETECTION SYSTEMIdaho Technology, Inc.2005-11-18NHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851458005006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851458005006008514580050068514580050060851458005006

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen prior to amplification, and generally operates with reduced technician involvement and automation of some, but not all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-262-3592support@biofiredefense.com

Regulatory Flags#

DUNS number
556915205
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851458005327SPOTFIRE Control Station - ITARFAST-ASY-0001-AFAST-ASY-0001-A2025-12-16
00851458005334SPOTFIRE Control Station - non-ITARFAST-ASY-0001-BFAST-ASY-0001-B2025-12-16
00851458005303BioFire Warrior PanelNGDS-ASY-0018NGDS-ASY-00182025-08-10
00851458005310BioFire Warrior Panel Control KitDFA2-ASY-0047DFA2-ASY-00472025-08-10
00851458005297FILMARRAY® COMMERCIAL LAPTOPCOMP-SUB-0034COMP-SUB-00342024-03-19
00851458005051FilmArray® 2.0 Instrument NGDS ConfigurationNGDS-ASY-0002NGDS-ASY-00022017-10-27
00851458005112FILMARRAY1.5FLM1-ASY-01212016-09-22
00851458005129FilmArray® 2.0 Instrument NGDS ConfigurationNGDS-ASY-0002NGDS-ASY-0002U2017-10-27
00851458005143FilmArray® 2.0 Instrument NGDS ConfigurationNGDS-ASY-0004NGDS-ASY-00042017-12-15
00851458005266FILMARRAY NGDS WARRIOR PANEL - CADFA2-ASY-0012DFA2-ASY-00122024-06-20
00851458005273BioFire® Global Fever Special Pathogens PanelDFA2-ASY-0018DFA2-ASY-00182023-08-31
00851458005280BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens PaneDFA2-ASY-0019DFA2-ASY-00192023-08-31
00851458005099NGDSNGDS-ASY-0006NGDS-ASY-00062017-04-21
00851458005136FilmArray® NGDS Warrior PanelNGDS-ASY-0007NGDS-ASY-00072017-10-24
00851458005242BioFire® Global Fever Panel DFA2-ASY-0004DFA2-ASY-00042021-07-16
00851458005259BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel DFA2-ASY-0006DFA2-ASY-00062021-07-16
00851458005228BioFire® COVID-19 Test 2DFA2-ASY-0015DFA2-ASY-00152023-02-16
00851458005235BioFire® COVID-19 Test 2DFA2-ASY-0016DFA2-ASY-00162023-02-16
00851458005020JBAIDSJRPD-ASY-0124JRPD-ASY-01242016-09-07
00851458005013JBAIDSJRPD-ASY-0016JRPD-ASY-00162016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851458005037JBAIDSBIOFIRE DEFENSE, LLCNHT2016-09-07