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IRISpec CA/CB Twinset

by Iris International, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10837461001973 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  • Withdrawn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
IRISpec
Generic Name
Multiple urine analyte IVD, control
Model / Ref / Catalog
CA/CB Twinset, 800-7211
Primary DI / UDI-DI
10837461001973
FDA Product Code
JJW
GMDN Term
Multiple urine analyte IVD, control
Device Class
Class I
Regulation Number
862.1660
GUDID distribution status
Not in Commercial Distribution

Other devices from Iris International, Inc.

Properties

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

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No