FDA.reportPublic FDA data

Oncomine™ Dx Target Test

Primary DI
10190302006385
Brand
Oncomine™ Dx Target Test
Company
LIFE TECHNOLOGIES CORPORATION
Model
A32441
Device description
ONC UNIV DX RNA/DNA PANEL IVD
Published
2017-06-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PQPNext generation sequencing oncology panel, somatic or germline variant detection system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQPNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160045000Oncomine Dx Target TestLife Technologies Corporation2017-06-22PQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190302006385PrimaryGS10
80190302006384Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030200638510190302006385
8019030200638480190302006384

GMDN Terms#

Term, Definition table
TermDefinition
Multiple tissue-associated protein/tumour marker IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple proteins or tumour markers associated with specific tissues in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790376870
Device count
48
Lot or batch
true
Expiration date on label
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
00850002748093Guardant360 CDxGuardant Health, Inc.PQP2026-06-07
00850002748079Guardant360 CDxGuardant Health, Inc.PQP2026-06-04
00850002748277Guardant360 Liquid CDxGuardant Health, Inc.PQP2026-05-29
00860008613325MI Cancer Seek®CARIS MPI, INC.PQP2025-04-30
00816270020217TruSight™ Oncology Comprehensive ILLUMINA, INC.PQP2024-12-09
00850059806005Resolution ctDx FIRST Sample Collection KitResolution Bioscience, Inc.PQP2024-03-31
10190302017756Oncomine™ Dx Target Test User Guides and Assay Definition FileLIFE TECHNOLOGIES CORPORATIONPQP2022-01-23
00860001218220oncoReveal CDxPillar Biosciences, Inc.PQP2021-09-20
00860001218237oncoReveal CDx Box 2Pillar Biosciences, Inc.PQP2021-09-20
00860001218244oncoReveal CDx Box 3Pillar Biosciences, Inc.PQP2021-09-20
00860001218251oncoReveal CDxPillar Biosciences, Inc.PQP2021-09-20
00860001218275PiVAT SoftwarePillar Biosciences, Inc.PQP2021-09-20
00860001218282oncoReveal CDxPillar Biosciences, Inc.PQP2021-09-20
10190302014335Oncomine™ Dx Target RNA Control DiluentLIFE TECHNOLOGIES CORPORATIONPQP2021-01-14
10190302015134Oncomine™ DX Target DNA Control v2.0LIFE TECHNOLOGIES CORPORATIONPQP2021-01-14
10190302015646Oncomine™ Dx Target Test User Guide and Assay Definition FileLIFE TECHNOLOGIES CORPORATIONPQP2021-01-14
10190302015103Oncomine™ Dx Target TestLIFE TECHNOLOGIES CORPORATIONPQP2019-05-22
10190302000888Ion TorrentLIFE TECHNOLOGIES CORPORATIONPQP2018-06-28
10190302005845Ion TorrentLIFE TECHNOLOGIES CORPORATIONPQP2018-06-28
10190302005852Ion TorrentLIFE TECHNOLOGIES CORPORATIONPQP2018-06-28
00816270020088Praxis Extended RAS PanelILLUMINA, INC.PQP2017-08-28
10190302006071Oncomine™ Dx Target Test User Guides and Assay Definition FileLIFE TECHNOLOGIES CORPORATIONPQP2017-06-27
10190302006156Ion Torrent™ Dx No Template Control KitLIFE TECHNOLOGIES CORPORATIONPQP2017-06-27
10190302006064Oncomine™ Dx Target RNA Control KitLIFE TECHNOLOGIES CORPORATIONPQP2017-06-27
10190302006095Oncomine™ Dx Target DNA Control KitLIFE TECHNOLOGIES CORPORATIONPQP2017-06-27