Skip to content

Access Ferritin (Reagent Pack)

by Beckman Coulter Inc.

Ref C22490Model 33020

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

CE IVDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K234052↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number15099590772840 UDI-DI Date5 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK234052 Date20 Mar 2024IssuedStatusActive
European UnionCE/IVDR EUDAMED Number150995901AccFerRX Basic UDI-DI Date2 May 2022RegisteredStatusActive

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

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Access Ferritin (Reagent Pack) EUDAMED
Access Ferritin EUDAMEDGUDID
Generic Name
Ferritin IVD, kit, enzyme immunoassay (EIA)
Device Name
Access Ferritin Reagent Pack
Model / Ref / Catalog
33020, C22490
Primary DI / UDI-DI
15099590772840, 15099590817879
Basic UDI-DI
150995901AccFerRX, 150995909AccFerW7
FDA Product Code
JMG
EMDN Code
W0102070102 Ferritin
GMDN Term
Ferritin IVD, kit, enzyme immunoassay (EIA)
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
866.5340
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

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

  • Animal Tissues
  • Reagent
  • Professional Testing
  • New Device NoEUDAMEDYesEUDAMED
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: 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