FDA.reportPublic FDA data

FilmArray® Torch Module

Primary DI
00815381020284
Brand
FilmArray® Torch Module
Company
BIOFIRE DIAGNOSTICS, LLC
Model
HTFA-SUB-0103
Catalog number
HTFA-SUB-0103R
Device description
Refurbished IVD instrument (Torch Module)
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K160068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160068000FilmArray Respiratory Panel (RP) for use with FilmArray TorchBiofire Diagnostics, LLC2016-02-08OCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815381020284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815381020284008153810202848153810202840815381020284

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079280262
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini4245372024-07-26
00815381020055BIOFIRE ® SPOTFIRE ® Control StationFAST-ASY-00012023-04-06
00815381020352BIOFIRE ® SPOTFIRE ® Control StationFAST-ASY-0001-W2023-04-06
00815381020369BIOFIRE ® SPOTFIRE ® ModuleFAST-ASY-00022023-04-06
00815381020376BIOFIRE ® SPOTFIRE ® ModuleFAST-ASY-0002-W2023-04-06
00815381029058FilmArray® 2.0 InstrumentFLM2-ASY-0001-W2021-06-21
00815381029072FilmArray® Torch System BaseHTFA-ASY-0001-W2021-06-21
00815381029089FilmArray® Torch ModuleHTFA-ASY-0003-W2021-06-21
00815381020017FilmArray® InstrumentFLM1-ASY-0001FLM1-ASY-00012016-09-23
00815381020024FilmArray® InstrumentFLM1-ASY-0001FLM1-ASY-0001R2016-09-23
00815381020031FilmArray® 2.0 InstrumentFLM2-ASY-0001FLM2-ASY-00012016-09-23
00815381020048FilmArray® 2.0 InstrumentFLM2-ASY-0001FLM2-ASY-0001R2016-09-23
00815381020253FilmArray® Torch System BaseHTFA-ASY-0104HTFA-ASY-01042016-08-01
00815381020260FilmArray® Torch System BaseHTFA-ASY-0104HTFA-ASY-0104R2016-09-23
00815381020277FilmArray® Torch ModuleHTFA-SUB-0103HTFA-SUB-01032016-08-10
00815381020208BioFire® Joint Infection (JI) PanelRFIT-ASY-01352025-02-18
00815381020345BioFire® Blood Culture Identification 2 (BCID2) PanelRFIT-ASY-01482025-02-18
00815381020888BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid4248982025-02-18
00815381020963BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid4250892025-02-18
00815381021007BIOFIRE® FILMARRAY® Tropical Fever Panel4248032025-02-18

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07613336206355cobas® 6800 systemRoche Molecular Systems, Inc.NSU2026-03-26
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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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06974849369403EudemonTM AIO800Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NSU2024-11-14
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