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I.S.E. Ref D200-0017

by Randox Laboratories, Ltd.

I.S.E. Ref D200-0017 is a Class II device made by Randox Laboratories, Ltd., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05055273210552), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055273210552 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
I.S.E. Ref
Generic name
Reference electrode IVD
Model / Ref / Catalog
D200-0017
Primary DI / UDI-DI
05055273210552
FDA product code
JGS, CEM, CGZ
GMDN term
Reference electrode IVD
Device class
Class II
Regulation number
862.1665, 862.1600, 862.1170
GUDID distribution status
In Commercial Distribution

Related devices

Category: Reference electrode IVD

Other devices from Randox Laboratories, Ltd.

See all devices from Randox Laboratories, Ltd. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)