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Rabs RP8398

by Randox Laboratories, Ltd.

Rabs RP8398 is a medical device (FDA Class I; FDA product code JJE, Analyzer, Chemistry (Photometric, Discrete), For Clinical Use) made by Randox Laboratories, Ltd., listed in FDA GUDID since 26 Sep 2016 (UDI-DI 05055273214307), 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 Number05055273214307 UDI-DI Date26 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  • Withdrawn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
Rabs
Generic name
Optical laboratory instrument performance standard calibrator/control IVD, single-use
Model / Ref / Catalog
RP8398
Primary DI / UDI-DI
05055273214307
FDA product code
JJE
GMDN term
Optical laboratory instrument performance standard calibrator/control IVD, single-use
Device class
Class I
Regulation number
862.2160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Optical laboratory instrument performance standard calibrator/control IVD, single-use

Similar devices in this category

Other devices filed under Optical laboratory instrument performance standard calibrator/control IVD, single-use.

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)