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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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 in one or more of the following: select treatment options; predict or monitor the response to cancer therapy; risk assessment of cancer development, recurrence or metastasis; and/or for tumour profiling (e.g., cell-free DNA or circulating tumour DNA screening).

Regulatory Flags#

DUNS number
202829982
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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