FDA.reportPublic FDA data

Torrent Suite DX SW, Installer V5.14.2

Primary DI
10190302019958
Brand
Torrent Suite DX SW, Installer V5.14.2
Company
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Model
A40001728
Device description
Torrent Suite Dx SW, Installer V5.14.2
Published
2025-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PFFHigh throughput DNA sequence analyzer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFFHigh Throughput Dna Sequence AnalyzerImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190302019958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030201995810190302019958

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDAn in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
628548377
Device count
1
DM exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190302017794Ion Torrent™ Genexus™ Dx Integrated SequencerA532562025-10-13
10190302017800Ion Torrent™ Genexus™ Dx Purification instrumentA532572025-10-13
10190302019897Applied BioSystems™ ABY™ Dye Spectral Calibration Plate for Multiplex qPCR, FastA654872025-08-19
10190302019903Applied BioSystems™ JUN™ Dye Spectral Calibration Plate for Multiplex qPCR, FastA654882025-08-19
10190302018883Ion Torrent Genexus Dx Software6.8A563322025-07-24
10190302018944VeritiPro Dx Thermal CyclerA558262023-05-25
10190302017329Applied BiosystemsA512202022-05-01
10190302017336Applied BiosystemsA512222022-05-01
10190302016148QuantStudio™ 7 Pro Dx Real-Time PCR SystemA507452021-12-10
10190302016155QuantStudio™ 7 Pro Dx 96-Well BlockA511952021-12-10
10190302016162QuantStudio™ 7 Pro Dx 96-Well Heated CoverA511972021-12-10
10190302015592Applied Biosystems™ QuantStudio™ 5 Dx Real-Time PCR SystemA473242021-02-01
101903020002227500 Fast Dx Real-Time PCR  Instrument75032016-08-01
10190302000512Veriti™ Dx 96-Well Fast Thermal Cycler99112016-08-01
10190302000529Veriti™ Dx 96-Well Thermal Cycler99122016-08-01
10190302000536Veriti™ Dx 384-Well Thermal Cycler99132016-08-01
10190302000857Ion One Touch™ DxONE TOUCH DX2016-08-01
10190302000864Ion One Touch™ ES DxONE TOUCH ES DX2016-08-01
10190302000697QuantStudioTM Dx Real-Time PCR Instrument87882016-08-01
10190302000734Lamp, Halogen RC, IVD44809142016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10190302017794Ion Torrent™ Genexus™ Dx Integrated SequencerLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2025-10-13
10190302018883Ion Torrent Genexus Dx SoftwareLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2025-07-24
10190302017848Torrent Suite DX SW, Installer V5.14LIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2023-03-20
00816270020637NovaSeq™ 6000DxILLUMINA, INC.PFF2022-10-18
00816270020699MiSeq™ Dx (China)ILLUMINA, INC.PFF2022-04-25
10190302016810Torrent Suite DX, Installer v5.12.5LIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2022-01-04
10190302014090Torrent Suite DX, Installer v5.8LIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2019-03-27
00816270020125NextSeq 550Dx Sequencing SystemILLUMINA, INC.PFF2018-02-09
10190302005654Torrent Suite™ Dx SW, V5.6.4LIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2017-08-15
08885013950069Sentosa ST401iVELA OPERATIONS SINGAPORE PTE. LTD.PFF2017-03-28
08885013950076Sentosa ST401eVELA OPERATIONS SINGAPORE PTE. LTD.PFF2016-10-19
08885013950045Sentosa SQ301 SequencerVELA OPERATIONS SINGAPORE PTE. LTD.PFF2016-09-22
00816270020002MiSeqDx InstrumentILLUMINA, INC.PFF2016-09-20
10190302000833Personal Genome Machine™ Dx (PGM™) DxLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2016-08-01
10190302000840Ion PGM™ Dx Chip MinifugeLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2016-08-01
10190302000857Ion One Touch™ DxLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2016-08-01
10190302000864Ion One Touch™ ES DxLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2016-08-01