FDA.reportPublic FDA data

Guardant360 CDx

Primary DI
00850002748079
Brand
Guardant360 CDx
Company
Guardant Health, Inc.
Model
GH10005
Published
2026-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
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
P200010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200010000Guardant360 CDxGuardant Health, Inc.2020-08-07PQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002748079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002748079008500027480798500027480790850002748079

GMDN Terms#

Term, Definition table
TermDefinition
Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended for the qualitative and/or quantitative detection of mRNA expression and/or determination of the gene mutation status of multiple genes associated with cancer in a clinical specimen, using a nucleic acid technique (NAT). It is intended to be used to select treatment options, predict or monitor the response to cancer therapy and the risk of recurrence or metastasis, and/or for tumour profiling (e.g., cell-free DNA or circulating tumour DNA screening).

Regulatory Flags#

DUNS number
119012278
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002748277Guardant360 Liquid CDxGH101092026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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