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Guardant360 Liquid CDx GH10109

by Guardant Health, Inc. United States GUDID

Product code PQP

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850002748277 UDI-DIDate29 May 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

GUDID · synced 23 Oct 2026

Trade Name
Guardant360 Liquid CDx
Generic Name
Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Model / Reference
GH10109
Primary DI / UDI-DI
00850002748277
PMA Number
FDA Product Code
PQP
GMDN Term
Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Device Class
Class III
Commercial Distribution
In Commercial Distribution

Other devices from Guardant Health, Inc.

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
Other properties (12)
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI 9e0db1bb-b786-4a8d-b6bd-1dc47ce48be6 33 fields · synced 23 Oct 2026