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oncoReveal CDx HDA-LC-2001-48-1

by Pillar Biosciences, 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 Number00860001218220 UDI-DI Date20 Sep 2021ListedStatusListed 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  • Withdrawn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
oncoReveal CDx
Generic Name
Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
HDA-LC-2001-48-1
Primary DI / UDI-DI
00860001218220
FDA Product Code
PQP
GMDN Term
Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
Device Class
Class III
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: oncoReveal® CDx Pan-Cancer Solid Tumor

Related devices

Category: Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)

Other devices from Pillar Biosciences, Inc.

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No