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AX-4280 Specific Gravity Calibrator Set (NA)

by Iris International, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10837461008002 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  • Withdrawn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
Ax-4280
Generic Name
Multiple urine analyte IVD, control
Model / Ref / Catalog
Specific Gravity Calibrator Set (NA), 800-3517
Primary DI / UDI-DI
10837461008002
FDA Product Code
KQO
GMDN Term
Multiple urine analyte IVD, control
Device Class
Class I
Regulation Number
862.2900
GUDID distribution status
Not in Commercial Distribution

Other devices from Iris International, Inc.

Properties

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

Other properties (8)

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