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R2450030

by Remel, Inc.

Ref R2450030

R2450030 is a device classified as IVD General (EU), Class II (US) made by Remel, Inc., registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI B-00848838026867) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00848838026867), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00848838026867 Basic UDI-DI 00848838026867UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848838026867 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00848838026867 registered 2 Sep 2026 Active
  • FDA GUDID UDI-DI 00848838026867 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00848838026867
  2. Registered EUDAMED B-00848838026867

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  • Withdrawn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 Giardia Control Kit
Generic name
Giardia lamblia antigen IVD, control
Model / reference
R2450030
Primary DI / UDI-DI
00848838026867
Basic UDI-DI
B-00848838026867
FDA product code
MHI
EMDN code
W01040699 Controls, standards, calibrators, microbiology - other
GMDN term
Giardia lamblia antigen IVD, control
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
866.3220
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 II

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

Related devices

Category: Giardia lamblia antigen IVD, control

Similar devices in this category

Other devices filed under CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER.

Other devices from Remel, Inc.

See all devices from Remel, Inc. →

Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)