Skip to content

IOTest CD3-PC7

by Beckman Coulter Inc. EUDAMEDGUDID

Active European Union

Ref 737657

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED NumberB-737657RX Basic UDI-DIDate8 Jun 2022RegisteredStatusActive
European UnionCE/IVDD EUDAMED NumberB-737657RX Basic UDI-DIDate8 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-737657RX UDI-DIDate23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
IOTest CD3-PC7 EUDAMED
IOTest CD3-PC7 (IVD not sold in the US or Canada) GUDID
Generic Name
Multiple CD cell marker IVD, antibody
Device Name
Monoclonal Antibody
Model / Ref / Catalog
737657
Primary DI / UDI-DI
D-737657RX, 15099590391553
Basic UDI-DI
B-737657RX, 150995901LSANTIBODYREAQ2
FDA Product Code
GKZ
EMDN Code
W0103080199, W0103080101
GMDN Term
Multiple CD cell marker IVD, antibody
Device Class
Class IVD General EUDAMED
Class C EUDAMED
Class II GUDID
Regulation Number
864.5220
Market of Registration
Ireland
GUDID distribution status
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

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

  • Single Use
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human 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
  • Serial Number: No