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iChem®10SG Urine Chemistry Strips

by Iris International, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10837461002529 UDI-DIDate7 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
iChem
Generic Name
Urine analyser IVD, laboratory
Model / Ref / Catalog
iChem®10SG Urine Chemistry Strips, 800-7005
Primary DI / UDI-DI
10837461002529
FDA Product Code
KQO, LJX, JJQ, CDM, JIR, CEN, JMT, JIN, JJB, JMA, JIO, JIL
GMDN Term
Urine analyser IVD, laboratory
Device Class
Class I
Regulation Number
862.2900, 864.7675, 862.2300, 862.1785, 862.1645, 862.1550, 862.1510, 862.1435, 862.1115, 862.1095, 864.6550, 862.1340
GUDID distribution status
Not in Commercial Distribution

Other devices from Iris International, Inc.

Properties

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

Other properties (9)

  • Sterile: 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