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Remel R21238

by Remel, Inc.

Remel R21238 is a Class I device made by Remel, Inc., listed in FDA GUDID since 3 Jan 2023 (UDI-DI 00848838023354), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00848838023354 UDI-DI Date3 Jan 2023ListedStatusListed 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  • Withdrawn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
Remel
Generic name
Biological stain IVD
Model / Ref / Catalog
R21238
Primary DI / UDI-DI
00848838023354
FDA product code
JTO
GMDN term
Biological stain IVD
Device class
Class I
Regulation number
866.2660
GUDID distribution status
In Commercial Distribution

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Properties

  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)