Skip to content

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) GENESIS by GENESEEQ software GS6101

by Geneseeq Technology, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860013470982 UDI-DI Date29 Dec 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) GENESIS by GENESEEQ software
Generic Name
Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
GS6101
Primary DI / UDI-DI
00860013470982
FDA Product Code
PZM
GMDN Term
Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Device Class
Class II
Regulation Number
866.6080
GUDID distribution status
In Commercial Distribution

Other devices from Geneseeq Technology, Inc.

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No