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Resolution ctDx FIRST Sample Collection Kit 500029

by Resolution Bioscience, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

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 Number00850059806005 UDI-DI Date31 Mar 2024ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1358-2023 FDA Class III initiated 17 Feb 2023

    Distributed sample collection kit with an unapproved instruction for use.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Resolution ctDx FIRST Sample Collection Kit
Generic Name
Venous blood collection kit IVD
Model / Reference
500029
Primary DI / UDI-DI
00850059806005
PMA Number
FDA Product Code
PQP
GMDN Term
Venous blood collection kit IVD
Device Class
Class III
GUDID distribution status
Not in Commercial Distribution

Properties

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

Other properties (9)

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