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Au ODR3029

by Beckman Coulter, Inc.

Ref ODR3029

Au ODR3029 is an in vitro diagnostic device (EU IVDR Class B; FDA Class II; FDA product code JIT, Calibrator, Secondary) made by Beckman Coulter, Inc., registered in EUDAMED on 21 Jun 2022 (Basic UDI-DI 150995901ODR3029EE), cleared under FDA 510(k) K032285 on 21 Aug 2003 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 15099590080839), active as of 23 Oct 2026.

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

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K032285

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/IVDR EUDAMED Number150995901ODR3029EE Basic UDI-DI 15099590080839UDI-DIDate21 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590080839 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK032285 Date21 Aug 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 150995901ODR3029EE registered 21 Jun 2022 Active
  • FDA 510(k) K032285 decided 21 Aug 2003 Active
  • FDA GUDID UDI-DI 15099590080839 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K032285
  2. Listed FDA GUDID 15099590080839
  3. Registered EUDAMED 150995901ODR3029EE

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Prealbumin Calibrator EUDAMED
Au GUDID
Generic name
Prealbumin (transthyretin) IVD, calibrator
Model / reference
ODR3029
Primary DI / UDI-DI
15099590080839
Basic UDI-DI
150995901ODR3029EE
510(k) Number
FDA product code
JIT
EMDN code
W0102152203 Specific protein standards and calibrators
GMDN term
Prealbumin (transthyretin) IVD, calibrator
Device class
Class B EUDAMED
Class II GUDID
Regulation number
862.1150
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class B
GUDID
Class II

Device class is stated on each registry's own scale: Class B 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: Prealbumin (transthyretin) IVD, calibrator

Similar devices in this category

Other devices filed under SPECIFIC PROTEIN STANDARDS AND CALIBRATORS.

Other devices from Beckman Coulter, Inc.

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Properties

  • Single use
  • Contains human tissues or cells
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)