What is FDA product code PZM?

A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens obtained from patients diagnosed with malignant solid neoplasms using targeted next-generation sequencing.

Immunology & Microbiology › Tumor Antigen Test SystemsNext Generation Sequencing Based Tumor Profiling Test

Geneseeqprime NGS Tumor Profiling Assay (Ffpe) Genesis by Geneseeq Software

Name: Geneseeqprime NGS Tumor Profiling Assay (Ffpe) Genesis by Geneseeq software
Brand: Geneseeqprime NGS Tumor Profiling Assay (Ffpe) Genesis by Geneseeq software

Catalogue number GS6101, listed by Geneseeq Technology Inc., Canada, under Next Generation Sequencing Based Tumor Profiling Test. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PZM
Manufacturer	City	Province	Registered as	Device types
Geneseeq Medical Device AND Diagnostic Inc.	Nanjing	Jiangsu	Contract manufacturer	1

Record

Regulatory record for Geneseeqprime NGS Tumor Profiling Assay (Ffpe) Genesis by Geneseeq software
Listed by	Geneseeq Technology Inc., Canada
FDA product code	PZM
Device type	Next Generation Sequencing Based Tumor Profiling Test
Device class	Class 2
Regulation	21 CFR 866.6080
Establishment	Specification developer, Manufacturer
Record published	2025-12-29

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Geneseeqprime NGS Tumor Profiling Assay (Ffpe) Genesis by Geneseeq software
Catalogue number	Size	Status
GS6101		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
PGDx elio™ server	Personal Genome Diagnostics Inc.	4
PGDx elio™ tissue complete	Personal Genome Diagnostics Inc.	2
Geneseeqprime NGS Tumor Profiling Assay (Ffpe)	Geneseeq Technology Inc.	1
PGDx elio™ platform	Personal Genome Diagnostics Inc.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K250003	2025-08-29

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.