FDA.reportPublic FDA data

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) GENESIS by GENESEEQ software

Primary DI
00860013470982
Brand
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) GENESIS by GENESEEQ software
Company
Geneseeq Technology Inc
Model
GS6101
Catalog number
GS6101
Published
2025-12-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PZMNext Generation Sequencing Based Tumor Profiling Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZMNext Generation Sequencing Based Tumor Profiling TestPathology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013470982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013470982008600134709828600134709820860013470982

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
202829982
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013470999GENESEEQPRIME NGS Tumor Profiling Assay (FFPE)GS6005GS60052025-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013470999GENESEEQPRIME NGS Tumor Profiling Assay (FFPE)Geneseeq Technology IncPZM2025-12-29
00192721001449PGDx elio™ serverPERSONAL GENOME DIAGNOSTICS INC.PZM2020-11-17
00192721001456PGDx elio™ serverPERSONAL GENOME DIAGNOSTICS INC.PZM2020-11-17
00192721001432PGDx elio™ serverPERSONAL GENOME DIAGNOSTICS INC.PZM2020-07-08
00192721000756PGDx elio™ serverPERSONAL GENOME DIAGNOSTICS INC.PZM2020-05-11
00192721000763PGDx elio™ platformPERSONAL GENOME DIAGNOSTICS INC.PZM2020-05-11
00192721000770PGDx elio™ tissue completePERSONAL GENOME DIAGNOSTICS INC.PZM2020-05-11
00192721001418PGDx elio™ tissue completePERSONAL GENOME DIAGNOSTICS INC.PZM2020-05-11