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R2450530

by Remel, Inc.

Ref R2450530

R2450530 is a device classified as IVD General (EU), Class II (US) made by Remel, Inc., registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-00848838026881), cleared under FDA 510(k) K031834 on 10 Nov 2003 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00848838026881), active as of 25 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K031834

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00848838026881 Basic UDI-DI 00848838026881UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848838026881 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK031834 Date10 Nov 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00848838026881 registered 30 Sep 2026 Active
  • FDA 510(k) K031834 decided 10 Nov 2003 Active
  • FDA GUDID UDI-DI 00848838026881 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2432-2008 FDA Unclassified (pre-2012) initiated 11 Aug 2008

    Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive

Timeline

4 dated events

  1. Cleared FDA 510(k) K031834
  2. Recall initiated FDA recalls Z-2432-2008
  3. Listed FDA GUDID 00848838026881
  4. Registered EUDAMED B-00848838026881

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Xpect Giardia/Cryptosporidium Control Kit
Generic name
Multiple faecal parasite antigen IVD, control
Model / reference
R2450530
Primary DI / UDI-DI
00848838026881
Basic UDI-DI
B-00848838026881
510(k) Number
FDA product code
MHI
EMDN code
W01040699 Controls, standards, calibrators, microbiology - other
GMDN term
Multiple faecal parasite 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: Multiple faecal parasite antigen IVD, control

Cleared under the same submission (K031834)

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)