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IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M Reagent

by Beckman Coulter Inc.

Ref 447470

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K993547↗

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
European UnionCE/IVDR EUDAMED Number150995901447470LE Basic UDI-DI 15099590221218UDI-DIDate28 Dec 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590221218 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK993547 Date1 Feb 2000IssuedStatusActive

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-1146-04 FDA Unclassified (pre-2012) initiated 6 Jun 2003

    Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).

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  • Withdrawn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
IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M Reagent EUDAMED
Immage GUDID
Generic Name
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
447470
Primary DI / UDI-DI
15099590221218
Basic UDI-DI
150995901447470LE
FDA Product Code
CFN
EMDN Code
W0102010107 Immunoglobulin m
GMDN Term
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
866.5510
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

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

Other properties (14)

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