FDA.reportPublic FDA data

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE)

Primary DI
00860013470999
Brand
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE)
Company
Geneseeq Technology Inc
Model
GS6005
Catalog number
GS6005
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
00860013470999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013470999008600134709998600134709990860013470999

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
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013470982GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) GENESIS by GENESEEQ softwareGS6101GS61012025-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013470982GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) GENESIS by GENESEEQ softwareGeneseeq 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