FDA.reportPublic FDA data

3500 Dx CS2 Genetic Analyzer 8-capillary

Primary DI
10190302000642
Brand
3500 Dx CS2 Genetic Analyzer 8-capillary
Company
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Model
3500DxCS2
Published
2016-08-01
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
10190302000642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030200064210190302000642

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sequence analyser IVD, Sanger sequencingA mains electricity (AC-powered) semi-automated laboratory instrument intended to determine the sequence and fragment analysis of nucleotides in an isolated nucleic acid [deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] sample for genetic analysis of a clinical specimen using a Sanger sequencing technique. It is used to analyse a polymerase chain reaction (PCR) product (thermal nucleic acid cycler is not included) and consists of a capillary electrophoresis instrument with a fluorescence detector, and sample processing, data processing, and/or data display software. The device operates with reduced technician involvement and automation of some procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
628548377
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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
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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
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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
10190302000673Sequencing Standard v1.1, 3500 Dx SeriesLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PCA2016-08-03
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
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10190302000277SEPTA, Cathode Buffer CNTR 3500LIFE TECHNOLOGIES CORPORATIONPCA2016-08-01
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