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Remel R246003

by Remel, Inc.

Ref R246003

Remel R246003 is a device classified as IVD General (EU), Class I (US) made by Remel, Inc., registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-00848838063701) and listed in FDA GUDID since 12 Nov 2021 (UDI-DI 00848838063701), 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-00848838063701 Basic UDI-DI 00848838063701UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848838063701 UDI-DI Date12 Nov 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00848838063701 registered 30 Sep 2026 Active
  • FDA GUDID UDI-DI 00848838063701 listed 12 Nov 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00848838063701
  2. Registered EUDAMED B-00848838063701

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  • Withdrawn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
Xpect Flu a&B Control 20SWAB/Set Kt/2SET EUDAMED
Remel GUDID
Generic name
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Device name
Xpect Flu a&B Control Swabs
Model / reference
R246003
Primary DI / UDI-DI
00848838063701
Basic UDI-DI
B-00848838063701
FDA product code
GNX
EMDN code
W0105040604 Influenza & para influenza
GMDN term
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
866.3330
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: Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Similar devices in this category

Other devices filed under INFLUENZA & PARA INFLUENZA.

Other devices from Remel, Inc.

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Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)