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Access Unconjugated Estriol (Calibrators)

by Beckman Coulter Inc. 2 variants

Ref 33575

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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K012900↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number150995901AccuE3CalE8 Basic UDI-DI Date3 Dec 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590231149 UDI-DI Date23 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK012900 Date16 Oct 2001IssuedStatusActive

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 24 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  • Withdrawn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
Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
33575
Primary DI / UDI-DI
15099590231149, 15099590816742
Basic UDI-DI
150995901AccuE3CalE8, 150995909AccuE3CalMG
FDA Product Code
JIT
EMDN Code
W0102152299 Standards and calibrators - immunochemistry - other
GMDN Term
Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
862.1150
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

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

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

Other properties (14)

  • 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
  • Serial Number: No