FDA.reportPublic FDA data

Cathode Buffer Container, 3500 Dx Series

Primary DI
10190302000239
Brand
Cathode Buffer Container, 3500 Dx Series
Company
LIFE TECHNOLOGIES, CORPORATION
Model
4408258
Device description
CATHOD BFR CONTAINR 3500DX SER
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
10190302000239PrimaryGS10
80190302000238Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030200023910190302000239
8019030200023880190302000238

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVDA buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078441189
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
10190302000185Anode Buffer Container, 3500 Dx Series43939252016-08-01
10190302000154POP-6™ (960) Performance Optimized Polymer, 3500 Dx Series43937112016-08-01
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
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