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DxU D38584

by Beckman Coulter, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number15099590811778 UDI-DIDate18 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
DxU
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Model / Reference
D38584
Primary DI / UDI-DI
15099590811778
510(k) Number
FDA Product Code
JJB, CDM, CEN, LJX, JIL, JIN, JIO, JIR, JMA, JMT
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Device Class
Class I
Regulation Number
862.1115, 862.1785, 862.1550, 864.7675, 862.1340, 862.1435, 864.6550, 862.1645, 862.1095, 862.1510
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K232317)

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

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

Other properties (10)

  • 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
  • Serial Number: No