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I.S.E. Na D200-0014

by Randox Laboratories, Ltd.

I.S.E. Na D200-0014 is a Class II device made by Randox Laboratories, Ltd., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05055273210521), 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 Number05055273210521 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  • Withdrawn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. Na
Generic name
Sodium (Na+) electrode IVD
Model / Ref / Catalog
D200-0014
Primary DI / UDI-DI
05055273210521
FDA product code
JGS
GMDN term
Sodium (Na+) electrode IVD
Device class
Class II
Regulation number
862.1665
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sodium (Na+) electrode IVD

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Other devices filed under Sodium (Na+) electrode IVD.

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Properties

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