FDA.reportPublic FDA data

3500Dx Series Polymer Pouch Caps

Primary DI
10190302000680
Brand
3500Dx Series Polymer Pouch Caps
Company
LIFE TECHNOLOGIES CORPORATION
Model
4462785
Device description
KIT,POUCH CAP IVD 3500
Published
2016-08-18
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190302000680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030200068010190302000680

GMDN Terms#

Term, Definition table
TermDefinition
Test tube/reservoir capA covering intended to be used to seal the top of a test tube or reagent reservoir to protect the contents against contamination from the external environment, and to prevent spillage and/or evaporation of contents during transportation or processing. The top of the cap may be penetrable to enable injection or aspiration of contents. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
182158873
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190302018449QuantStudio™ 7 Pro Dx Software, V3.0.0A546262022-09-12
10190302018159appliedbiosystems QuantStudioTM 7 Pro Dx SoftwareA52649, V2.0.02022-05-02
10190302017862QuantStudio™ 7 Pro Dx SoftwareA52015, V1.0.52021-12-10
10190302002691Dulbecco's Phosphate Buffered Saline (D-PBS)140401412016-08-04
10190302000635Dulbecco's Phosphate Buffered Saline (D-PBS)141901362016-08-01
10190302002684Hanks' Balanced Salt Solution (HBSS)140250922016-08-04
10190302002721Dulbecco's Phosphate Buffered Saline (D-PBS)140401332016-08-04
10190302002837Hanks' Balanced Salt Solution (HBSS)141701122016-08-04
10190302002844Hanks' Balanced Salt Solution (HBSS)141750952016-08-04
10190302002875Hanks' Balanced Salt Solution (HBSS)141750792016-08-04
10190302003018Dulbecco's Phosphate Buffered Saline (D-PBS)142000752016-08-04
10190302003858Hanks' Balanced Salt Solution (HBSS)240201172016-08-04
10190302000628Dulbecco's Phosphate Buffered Saline (D-PBS)140401172016-08-01
10190302002950Dulbecco's Phosphate Buffered Saline (D-PBS)141901442016-08-01
10190302019439Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferA577402025-02-17
10190302018982TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayA564402025-02-17
10190302018999TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control9636122025-02-17
10190302019002TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control9636092025-02-17
10190302019019TaqPath™ 1-Step Select Master Mix (No ROX)A56518A561232025-02-17
10190302019026TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayA564412025-02-17

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
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
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