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IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein Reagent

by Beckman Coulter Inc.

Ref 447780

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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K964257↗

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
European UnionCE/IVDR EUDAMED Number150995901447780LY Basic UDI-DI 15099590224066UDI-DIDate31 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590224066 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK964257 Date24 Mar 1997IssuedStatusActive

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 25 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  • Withdrawn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
IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein Reagent EUDAMED
Immage GUDID
Generic Name
Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
447780
Primary DI / UDI-DI
15099590224066
Basic UDI-DI
150995901447780LY
FDA Product Code
LKL
EMDN Code
W0102019001 A1-acid glycoprotein (orosomucoid)
GMDN Term
Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
Device Class
Class C EUDAMED
Class I GUDID
Regulation Number
866.5420
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class C
GUDID
Class I

Manufacturer details

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

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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