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Urine Chemistry Strips DxU 11FA, 100 Strips/tube"

by Urit Medical Electronic Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number06935740751575 UDI-DI Date26 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Urine Chemistry Strips
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Model / Reference
DxU 11FA, 100 Strips/tube"
Primary DI / UDI-DI
06935740751575
510(k) Number
FDA Product Code
JIO, CDM, CEN, JFY, JIL, KQO, JIN, JIR, JJB, LJX, JMA, JMT, JRE
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Device Class
Class II
Regulation Number
864.6550, 862.1785, 862.1550, 862.1225, 862.1340, 862.2900, 862.1435, 862.1645, 862.1115, 864.7675, 862.1095, 862.1510, 862.2800
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K232317)

Other devices from Urit Medical Electronic Co., Ltd.

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Properties

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

Other properties (10)

  • Sterile: 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