Skip to content

Urine Reagent Strips URIT 12FA, 100 pcs/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 26 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06935740750615 UDI-DI Date16 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 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  • Withdrawn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 Reagent Strips
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Model / Reference
URIT 12FA, 100 pcs/tube
Primary DI / UDI-DI
06935740750615
510(k) Number
FDA Product Code
CEN, CDM, JFY, LJX, JIL, JIN, JIO, JIR, JJB, JMA, JMT, KQO, JRE
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Device Class
Class I
Regulation Number
862.1550, 862.1785, 862.1225, 864.7675, 862.1340, 862.1435, 864.6550, 862.1645, 862.1115, 862.1095, 862.1510, 862.2900, 862.2800
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K232317)

Other devices from Urit Medical Electronic Co., Ltd.

See all devices from Urit Medical Electronic Co., Ltd. →

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