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Access Total T4 II Calibrators C69048

by Beckman Coulter, Inc.

Ref C69048

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number150995909AccTT4IICalAE Basic UDI-DI Date18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590754495 UDI-DI Date19 Sep 2025ListedStatusListed 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.

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  • Withdrawn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
Access Total T4 II Calibrators
Generic Name
Thyroxine binding capacity IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
C69048
Primary DI / UDI-DI
15099590754495, 15099590818265
Basic UDI-DI
150995909AccTT4IICalAE, 150995901AccTT4IICalZ3
FDA Product Code
JIS
EMDN Code
W0102152299 Standards and calibrators - immunochemistry - other
GMDN Term
Thyroxine binding capacity IVD, kit, chemiluminescent immunoassay
Device Class
Class B 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 B
GUDID
Class II

Related devices

Category: Thyroxine binding capacity IVD, kit, chemiluminescent immunoassay

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Properties

  • Human Tissues
  • Reagent
  • Professional Testing
  • New Device
  • 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