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IMMUNOPREP Reagent System

by Beckman Coulter Inc.

Ref 7546999Model IMMUNOPREP REAGENT SYSTEM

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

CE IVDR

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/IVDR EUDAMED Number150995901LSPREPREAGENT35 Basic UDI-DI 15099590542443UDI-DIDate26 Apr 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590542443 UDI-DI Date23 Sep 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  • Withdrawn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/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
IMMUNOPREP Reagent System EUDAMED
Immunoprep Reagent Whole Blood Lysing GUDID
reticONE Reagent GUDID
Generic Name
White blood cell count IVD, reagent
Reticulocyte count IVD, reagent
Model / Ref / Catalog
IMMUNOPREP REAGENT SYSTEM, 7546999, 7547059
Primary DI / UDI-DI
15099590542443, 15099590537258
Basic UDI-DI
150995901LSPREPREAGENT35
FDA Product Code
GGK, GKZ
EMDN Code
W0103080699 Reagents for flow cytometry - other
GMDN Term
White blood cell count IVD, reagent
Reticulocyte count IVD, reagent
Device Class
Class A EUDAMED
Class I GUDID
Class II GUDID
Regulation Number
864.8540, 864.5220
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I
Class II

Manufacturer details

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

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Properties

  • Single Use
  • Reagent
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No