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Detergent for Automatic Urine Analyzer URIT D21, 5L

by Urit Medical Electronic Co., Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06935740750646 UDI-DIDate16 Apr 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  • Withdrawn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 22 Oct 2026.

Specification

GUDID

Trade Name
Detergent for Automatic Urine Analyzer
Generic Name
Instrument/analyser cleaning agent IVD
Model / Reference
URIT D21, 5L
Primary DI / UDI-DI
06935740750646
FDA Product Code
JCB
GMDN Term
Instrument/analyser cleaning agent IVD
Device Class
Class I
Regulation Number
864.4010
GUDID distribution status
In Commercial Distribution

Other devices from Urit Medical Electronic Co., Ltd.

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

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • 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
  • Serial Number: No