FDA.reportPublic FDA data

oncoReveal CDx

Primary DI
00860001218282
Brand
oncoReveal CDx
Company
Pillar Biosciences, Inc.
Model
HDA-LC-2001-48
Catalog number
HDA-LC-2001-4
Device description
oncoReveal CDx - Kit (Boxes 1 through 4)
Published
2021-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001218282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001218282008600012182828600012182820860001218282

GMDN Terms#

Term, Definition table
TermDefinition
Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict colorectal cancer, and/or select treatment options and/or monitor the response to cancer therapy, based on multiple disease-associated genotypes, which may include BRAF, KRAS, APC, NRAS, PIK3CA, and/or CTNNB1 gene mutations, using a nucleic acid technique (NAT).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
508-655-3027snyders@pillar-biosciences.com

Regulatory Flags#

DUNS number
117965650
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001218220oncoReveal CDxHDA-LC-2001-48-1HDA-LC-2001-48-12021-09-20
00860001218237oncoReveal CDx Box 2HDA-LC-2001-48-2HDA-LC-2001-48-22021-09-20
00860001218244oncoReveal CDx Box 3HDA-LC-2001-48-3HDA-LC-2001-48-32021-09-20
00860001218251oncoReveal CDxHDA-LC-2001-48-4HDA-LC-2001-48-42021-09-20
00860001218275PiVAT SoftwareSFW-2012 2.0SFW-20122021-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10190302006385Oncomine™ Dx Target TestLIFE TECHNOLOGIES CORPORATIONPQP2017-06-27
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