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IMMAGE Immunochemistry Systems CRP C-Reactive Protein Reagent

by Beckman Coulter Inc.

Ref 447280

Active European Union and United States

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) K981638↗

+1 more

Trust

Unverified

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

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-447280QA Basic UDI-DI D-447280QAUDI-DIDate8 Jun 2022RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK981638 Date12 Jun 1998IssuedStatusActive

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-0921-2010 FDA Unclassified (pre-2012) initiated 10 Jan 2008 on shared 510(k) K981638

    IMMAGE CRP Reagent lots M705441, M709279, & M709319, may demonstrate a prozone or hook effect on samples with extremely high CRP analyte concentration.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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)

Model / Reference
447280
Primary DI / UDI-DI
D-447280QA
Basic UDI-DI
B-447280QA
EMDN Code
W01021109 C-reactive protein
Device Class
Class IVD General
EU market of registration
Ireland

Manufacturer details

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

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No