FDA.reportPublic FDA data

FILMARRAY® COMMERCIAL LAPTOP

Primary DI
00851458005297
Brand
FILMARRAY® COMMERCIAL LAPTOP
Company
BIOFIRE DEFENSE, LLC
Model
COMP-SUB-0034
Catalog number
COMP-SUB-0034
Device description
FilmArray Commercial Laptop for use with the BIOFIRE FILMARRAY 2.0 instrument
Published
2024-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSUInstrumentation For Clinical Multiplex Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143178000FilmArray 2.0 SystemBiofire Diagnostics, LLC2015-01-30NSU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851458005297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851458005297008514580052978514580052970851458005297

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
556915205
Device count
1
Kit
true
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
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
00851458005006JBAIDSJB01JRPD-ASY-00012016-09-07
00851458005013JBAIDSJRPD-ASY-0016JRPD-ASY-00162016-09-07

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Primary DI, Brand, Company table
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07613336175941Digital LightCycler AnalyzerRoche Molecular Systems, Inc.NSU2026-09-24
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07613336206355cobas® 6800 systemRoche Molecular Systems, Inc.NSU2026-03-26
07613336206362cobas® 8800 systemRoche Molecular Systems, Inc.NSU2026-03-26
04049016126034EUROArrayScanEUROIMMUN Medizinische Labordiagnostika AGNSU2025-12-19
00851458005327SPOTFIRE Control Station - ITARBIOFIRE DEFENSE, LLCNSU2025-12-16
00851458005334SPOTFIRE Control Station - non-ITARBIOFIRE DEFENSE, LLCNSU2025-12-16
05060441760005binx ioBINX HEALTH LIMITEDNSU2025-09-03
10190302019897Applied BioSystems™ ABY™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
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00840487101858LIAISON PLEX Gram-Positive Blood Culture AssayLUMINEX CORPORATIONNSU2025-07-11
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04719880531103QLociLIFEOS GENOMICS CORPORATIONNSU2025-04-30
00850063063005DASH® Rapid PCR InstrumentNuclein, LLCNSU2025-01-06
00856826006203Applied BiosystemsAffymetrix, Inc.NSU2024-12-24
15420045517059Aptima®Hologic, Inc.NSU2024-12-19
15420045517066Aptima®Hologic, Inc.NSU2024-12-19
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15420045517080Aptima®Hologic, Inc.NSU2024-12-19
06974849369403EudemonTM AIO800Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NSU2024-11-14
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