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PGDx elio™ tissue complete B01104100

by Personal Genome Diagnostics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00192721001517 UDI-DI Date21 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PGDx elio™ tissue complete
Generic Name
Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
B01104100
Primary DI / UDI-DI
00192721001517
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
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (P250036)

Other devices from Personal Genome Diagnostics, Inc.

See all devices from Personal Genome Diagnostics, Inc. →

Properties

  • Lot / Batch Number
  • Expiration Date

Other properties (12)

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