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COULTER CYTO-TROL Control Cells Kit

by Beckman Coulter Inc. United States EUDAMEDGUDID

Ref 6604248Model Flow Cytometry Control Cells

Product code GGLEMDN W0103080403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-6604248ZA Basic UDI-DIDate7 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-6604248ZA UDI-DIDate23 Sep 2016ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/IVDD Expiring (legacy directive)
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
COULTER CYTO-TROL Control Cells Kit EUDAMED
Cyto-Trol Control Cells GUDID
Generic Name
Multiple CD cell marker IVD, control
Device Name
IMMUNO-TROL Cells
Model / Ref / Catalog
6604248, Flow Cytometry Control Cells
Primary DI / UDI-DI
D-6604248ZA, 15099590541972
Basic UDI-DI
B-6604248ZA, 150995901LSIMMUNOTROLXV
FDA Product Code
GGL
EMDN Code
W0103080403 Lymphocyte subtyping controls
GMDN Term
Multiple CD cell marker IVD, control
Device Class
Class IVD General EUDAMED
Class C EUDAMED
Class II GUDID
Regulation Number
864.8625
Market of Registration
Ireland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
Class C
GUDID
Class II

Manufacturer details

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

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Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Human Tissues NoEUDAMEDYesEUDAMED
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (15)
  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (3)

  • EUDAMED 0e778337-afe3-474f-8c3b-3f3b87590ff3 61 fields · synced 22 Oct 2026
  • EUDAMED 15099590541972|150995901LSIMMUNOTROLXV 61 fields · synced 16 May 2026
  • FDA UDI c773df97-9925-4d6c-9e21-53adb2595cf1 34 fields · synced 30 May 2026