Skip to content

R2451020

by Remel, Inc.

Ref R2451020

R2451020 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-00848838026898), cleared under FDA 510(k) K031965 on 14 Nov 2003 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00848838026898), active as of 23 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) K031965

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00848838026898 Basic UDI-DI 00848838026898UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848838026898 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK031965 Date14 Nov 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00848838026898 registered 30 Sep 2026 Active
  • FDA 510(k) K031965 decided 14 Nov 2003 Active
  • FDA GUDID UDI-DI 00848838026898 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1376-04 FDA Unclassified (pre-2012) initiated 9 May 2002

    A potential stability problem has been identified with the Positive Controls in the referenced kit lots of the ProSpecT Cryptosporidium Microplate Assay. The Positive Control may NOT perform as intended through its expiration date and may invalidate an otherwise acceptable run. Quality control testing indicates the other reagents in these kits are performing as intended.

Timeline

4 dated events

  1. Recall initiated FDA recalls Z-1376-04
  2. Cleared FDA 510(k) K031965
  3. Listed FDA GUDID 00848838026898
  4. Registered EUDAMED B-00848838026898

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  • Withdrawn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 Cryptosporidium Test Kit
Generic name
Cryptosporidium species antigen IVD, kit, rapid ICT, clinical
Model / reference
R2451020
Primary DI / UDI-DI
00848838026898
Basic UDI-DI
B-00848838026898
510(k) Number
FDA product code
MHJ
EMDN code
W0104050203 Cryptosporidium
GMDN term
Cryptosporidium species antigen IVD, kit, rapid ICT, clinical
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: Cryptosporidium species antigen IVD, kit, rapid ICT, clinical

Similar devices in this category

Other devices filed under PARASITOLOGY ( MICROBIOLOGY ).

Other devices from Remel, Inc.

See all devices from Remel, Inc. →

Properties

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