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StatSpin X00-003808-001

by Iris International, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10873037000766 UDI-DIDate24 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  • Withdrawn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
StatSpin
Generic Name
Metabolic profile clinical chemistry analyser IVD
Model / Ref / Catalog
X00-003808-001
Primary DI / UDI-DI
10873037000766
FDA Product Code
JPI
GMDN Term
Metabolic profile clinical chemistry analyser IVD
Device Class
Class II
Regulation Number
864.6400
GUDID distribution status
Not in Commercial Distribution

Other devices from Iris International, Inc.

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No