FDA.reportPublic FDA data

Torrent Suite™ Dx SW, V5.6.4

Primary DI
10190302005654
Brand
Torrent Suite™ Dx SW, V5.6.4
Company
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Model
A33178
Device description
KIT, TS DX SW V5.6.4
Published
2017-08-15
Public version status
Update
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
10190302005654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030200565410190302005654

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
10190302019958Torrent Suite DX SW, Installer V5.14.2LIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2025-02-19
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
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