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Access OV Monitor (Calibrators)

by Beckman Coulter Inc.

Ref 386358

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) K240479↗

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
United StatesFDA 510(k) 510(k) NumberK240479 Date10 May 2024IssuedStatusActive
European UnionCE/IVDR EUDAMED Number150995901AccOVMonCalTC Basic UDI-DI Date3 Dec 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590232375 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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

Generic Name
Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
386358
Primary DI / UDI-DI
15099590232375, 15099590817015
Basic UDI-DI
150995901AccOVMonCalTC, 150995909AccOVMonCal4P
FDA Product Code
LTK
EMDN Code
W0102152205 Tumour marker standards and calibrators
GMDN Term
Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
866.6010
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 II

Manufacturer details

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

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Properties

  • Human Tissues
  • Reagent
  • Professional Testing
  • New Device NoEUDAMEDYesEUDAMED
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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