Skip to content

Alkaline Phosphatase Reagent

by Beckman Coulter Inc. 2 variants

Ref 476821

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-476821RJ Basic UDI-DI D-476821RJUDI-DIDate9 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-476821RJ UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Alkaline Phosphatase Reagent EUDAMED
Synchron GUDID
Generic Name
Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry
Model / Ref / Catalog
476821
Primary DI / UDI-DI
D-476821RJ EUDAMED
15099590625689 GUDID
Basic UDI-DI
B-476821RJ
FDA Product Code
CJE
EMDN Code
W01010105 Alkaline phosphatase - total
GMDN Term
Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
862.1050
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-476821RJ
GUDID
15099590625689
Device ClassEUDAMED
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
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal 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