FDA.reportPublic FDA data

Ion Torrent™ Genexus™ Dx Integrated Sequencer

Primary DI
10190302017794
Brand
Ion Torrent™ Genexus™ Dx Integrated Sequencer
Company
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Model
A53256
Published
2025-10-13
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
10190302017794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030201779410190302017794

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)A mains electricity (AC-powered) automated laboratory instrument intended to determine the sequence of nucleotides in a nucleic acid library [pre-constructed from deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] for genetic analysis of a clinical specimen, using a next-generation sequencing (NGS) technique. It consists of a detector (e.g., fluorescent, luminescent or electrochemical) which detects signals from incorporated nucleotides, as well as sample processing, data processing, and/or data display software. It operates with minimal technician input and complete automation of all procedural steps.

Regulatory Flags#

DUNS number
628548377
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10190302019859Diomni™ Software, Version 4.2.0A400023232025-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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