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Remel R21144

by Remel, Inc.

Ref R21144

Remel R21144 is a device classified as IVD General (EU), Class I (US) made by Remel, Inc., registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI B-00848838023002) and listed in FDA GUDID since 12 Nov 2021 (UDI-DI 00848838023002), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00848838023002 Basic UDI-DI 00848838023002UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848838023002 UDI-DI Date12 Nov 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00848838023002 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 00848838023002 listed 12 Nov 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00848838023002
  2. Registered EUDAMED B-00848838023002

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Bactistaph Kit EUDAMED
Remel GUDID
Generic name
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Model / reference
R21144
Primary DI / UDI-DI
00848838023002
Basic UDI-DI
B-00848838023002
FDA product code
JWX
EMDN code
W0104080303 Staphylococci slide tests
GMDN term
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
866.2660
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class I

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Staphylococcus aureus culture isolate antigen IVD, kit, agglutination

Similar devices in this category

Other devices filed under STAPHYLOCOCCI SLIDE TESTS.

Other devices from Remel, Inc.

See all devices from Remel, Inc. →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)