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iQ®200 iQ® Lamina™ Cradle

by Iris International, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10837461002192 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  • Withdrawn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
iQ®200
Generic Name
Urine analyser IVD, laboratory
Model / Ref / Catalog
iQ® Lamina™ Cradle, 800-3105
Primary DI / UDI-DI
10837461002192
FDA Product Code
LKM
GMDN Term
Urine analyser IVD, laboratory
Device Class
Class II
Regulation Number
864.5200
GUDID distribution status
Not in Commercial Distribution

Other devices from Iris International, Inc.

Properties

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

Other properties (10)

  • 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
  • Manufacturing Date: No