Skip to content

IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent

by Beckman Coulter Inc.

Ref 447450

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

CE IVDR CE IVDD 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) K000121↗

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/IVDD EUDAMED Number150995901447450L8 Basic UDI-DI Date14 Sep 2023RegisteredStatusActive
European UnionCE/IVDR EUDAMED Number150995901447450L8 Basic UDI-DI Date14 Sep 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590221171 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK000121 Date17 May 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

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  • Withdrawn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
  • European Union CE/IVDD, CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent EUDAMED
Immage GUDID
Generic Name
Lipoprotein A IVD, reagent
Model / Ref / Catalog
447450
Primary DI / UDI-DI
15099590221171, D-447450QB
Basic UDI-DI
150995901447450L8, B-447450QB
FDA Product Code
DFC
EMDN Code
W0102010405 Lipoprotein ( a )
GMDN Term
Lipoprotein A IVD, reagent
Device Class
Class B EUDAMED
Class IVD General EUDAMED
Class II GUDID
Regulation Number
866.5600
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
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

  • Single Use
  • Human Tissues YesEUDAMEDNoEUDAMED
  • 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