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Access CEA Calibrators

by Beckman Coulter Inc.

Ref 33205

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

CE IVDD 510(k)

Valid until

Not listed

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) K223921↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK223921 Date22 Sep 2023IssuedStatusActive
European UnionCE/IVDD EUDAMED NumberB-33205FQ Basic UDI-DI D-33205FQUDI-DIDate7 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-33205FQ UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-0239-2016 FDA Class II initiated 13 Oct 2015

    Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
33205
Primary DI / UDI-DI
D-33205FQ EUDAMED
15099590624835 GUDID
Basic UDI-DI
B-33205FQ
510(k) Number
FDA Product Code
DHX
EMDN Code
W0102152203 Specific protein standards and calibrators
GMDN Term
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
866.6010
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-33205FQ
GUDID
15099590624835
Device ClassEUDAMED
Class IVD General
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000010288
Authorised representative
Beckman Coulter Ireland Inc. IE-AR-000000886

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (15)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No