FDA.reportPublic FDA data

Resolution ctDx FIRST Sample Collection Kit

Primary DI
00850059806005
Brand
Resolution ctDx FIRST Sample Collection Kit
Company
Resolution Bioscience, Inc.
Model
500029
Published
2024-03-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
P210040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P210040000RESOLUTION ctDx FIRSTExact Sciences Corporation2022-12-12PQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850059806005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850059806005008500598060058500598060050850059806005

GMDN Terms#

Term, Definition table
TermDefinition
Venous blood collection kit IVDA collection of in vitro diagnostic devices and materials intended for use by a healthcare professional at the point-of-care for the collection of a venous blood specimen, for subsequent diagnostic testing or screening. The kit typically includes venous access needle with tubing and connector, a blood collection tube(s) [with or without additives (e.g., sodium citrate)], and additional items (e.g., tourniquet, pipette, gauze pads, alcohol pads, dressings and a container with a requisition form, for mailing to the laboratory). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079831618
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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
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
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