FDA.reportPublic FDA data

Sequencing Standard v1.1, 3500 Dx Series

Primary DI
10190302000673
Brand
Sequencing Standard v1.1, 3500 Dx Series
Company
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Model
4462113
Device description
SEQUENCING STD BDT V1.1 DX
Published
2016-08-03
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
PCADNA genetic analyzer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCADna Genetic AnalyzerClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK110039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK110039000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190302000673PrimaryGS10
80190302000672Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030200067310190302000673
8019030200067280190302000672

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid hybridization detection IVD, controlA material which is used to verify the performance of an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinical specimen [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
628548377
Device count
4
DM exempt
true
Lot or batch
true
Expiration 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
101903020059373500 Dx Genetic AnalyzerLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PCA2020-04-24
101903020059443500xL Dx Genetic AnalyzerLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PCA2020-04-24
1019030200733796WELL RETAINER & BASE FASTLIFE TECHNOLOGIES CORPORATIONPCA2020-04-20
10190302000147POP-7 (384) Performance Optimized Polymer, 3500DxLIFE TECHNOLOGIES, CORPORATIONPCA2020-04-15
10190302000161POP-7 (960) Performance Optimized Polymer, 3500DxLIFE TECHNOLOGIES, CORPORATIONPCA2020-04-15
10190302006637DS-30 Matrix Standard Kit (Dye Set D) DxLIFE TECHNOLOGIES CORPORATIONPCA2020-04-15
10190302007078DS-33 Matrix Standard (Dye Set G5) - DxLIFE TECHNOLOGIES CORPORATIONPCA2020-04-15
10190302007092GeneScan™ 600 LIZ® Size Standard v2.0 DxLIFE TECHNOLOGIES CORPORATIONPCA2020-04-15
10190302014052DS-33 GeneScan™ Install Kit - DxLIFE TECHNOLOGIES CORPORATIONPCA2020-04-15
101903020150663500 Dx Series Data Collection Software 3 IVD Version 3.2LIFE TECHNOLOGIES CORPORATIONPCA2020-04-13
101903020006803500Dx Series Polymer Pouch CapsLIFE TECHNOLOGIES CORPORATIONPCA2016-08-18
10190302000185Anode Buffer Container, 3500 Dx SeriesLIFE TECHNOLOGIES, CORPORATIONPCA2016-08-01
10190302000239Cathode Buffer Container, 3500 Dx SeriesLIFE TECHNOLOGIES, CORPORATIONPCA2016-08-01
10190302000154POP-6™ (960) Performance Optimized Polymer, 3500 Dx SeriesLIFE TECHNOLOGIES, CORPORATIONPCA2016-08-01
10190302000178POP-6™ (384) Performance Optimized Polymer, 3500 Dx SeriesLIFE TECHNOLOGIES, CORPORATIONPCA2016-08-01
10190302000246Conditioning Reagent, 3500 Dx SeriesLIFE TECHNOLOGIES, CORPORATIONPCA2016-08-01
10190302000208CAPILLARY ARRAY 8-CAP 50CMLIFE TECHNOLOGIES CORPORATIONPCA2016-08-01
10190302000215CAPILLARY ARRAY 24-CAP 50CMLIFE TECHNOLOGIES CORPORATIONPCA2016-08-01
1019030200025396 WELL Retainer & Base STD CE-IVDLIFE TECHNOLOGIES CORPORATIONPCA2016-08-01
10190302000260SEPTA, 96 WELL CE-IVD 3500 LIFE TECHNOLOGIES CORPORATIONPCA2016-08-01
10190302000277SEPTA, Cathode Buffer CNTR 3500LIFE TECHNOLOGIES CORPORATIONPCA2016-08-01
101903020006423500 Dx CS2 Genetic Analyzer 8-capillaryLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PCA2016-08-01
101903020006593500 xL Dx CS2 Genetic Analyzer 24-capillaryLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PCA2016-08-01
10190302000666Pump cleaning Kit (3500Dx series)LIFE TECHNOLOGIES CORPORATIONPCA2016-08-01
10190302000192Hi-Di™ Formamide, 3500 Dx SeriesLIFE TECHNOLOGIES, CORPORATIONPCA2016-08-01