FDA.reportPublic FDA data

POP-6™ (960) Performance Optimized Polymer, 3500 Dx Series

Primary DI
10190302000154
Brand
POP-6™ (960) Performance Optimized Polymer, 3500 Dx Series
Company
LIFE TECHNOLOGIES, CORPORATION
Model
4393711
Device description
POP-6(960)POLYMR 3500DX SERIES
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
10190302000154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030200015410190302000154

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid hybridization detection IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in 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
078441189
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190302000185Anode Buffer Container, 3500 Dx Series43939252016-08-01
10190302000239Cathode Buffer Container, 3500 Dx Series44082582016-08-01
10190302000178POP-6™ (384) Performance Optimized Polymer, 3500 Dx Series43937162016-08-01
10190302000246Conditioning Reagent, 3500 Dx Series44095432016-08-01
10190302000192Hi-Di™ Formamide, 3500 Dx Series44043072016-08-01
10190302000147POP-7 (384) Performance Optimized Polymer, 3500Dx43937092020-04-15
10190302000161POP-7 (960) Performance Optimized Polymer, 3500Dx43937132020-04-15
10190302059015invitrogenA329982016-07-25

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
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