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Access Thyroglobulin Antibody II Reagent Pack A32898

by Beckman Coulter Inc. 2 variants

Ref A32898

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240996↗

+5 more

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
United StatesFDA 510(k) 510(k) NumberK240996 Date3 Jul 2024IssuedStatusActive
European UnionCE/IVDR EUDAMED Number150995901AccTGAb3P Basic UDI-DI 15099590202910UDI-DIDate2 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590202910 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

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0265-2025 FDA Class II initiated 5 Sep 2024

    IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.

    • Terminated Z-2242-2020 FDA Class II initiated 30 Apr 2019

    The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.

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  • Withdrawn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

Full name
Access Thyroglobulin Antibody II Reagent Pack
Trade Name
Access Thyroglobulin Antibody II Reagent Pack EUDAMED
Access Thyroglobulin Antibody II GUDID
Generic Name
Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
A32898
Primary DI / UDI-DI
15099590202910
Basic UDI-DI
150995901AccTGAb3P
FDA Product Code
JNL
EMDN Code
W0102100303 Thyroglobulin autoantibody
GMDN Term
Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
866.5870
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

Manufacturer details

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

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Access Thyroglobulin Antibody II Reagent Pack is a paramagnetic particle, chemiluminescent immunoassay reagent designed for the quantitative determination of thyroglobulin antibodies (TgAb) in human serum and plasma. Classified under nomenclature code W0102100303, it is intended for use with Beckman Coulter Access Immunoassay Systems to aid in the diagnosis of thyroid-related conditions by detecting anti-thyroglobulin antibodies.

This reagent pack is supplied as a professional-use diagnostic tool, containing animal-derived components, and is not sterile or single-use. It is supplied in packs of 50 tests (reference A32898) and requires compatibility with the Access Immunoassay Systems for operation. Authorised under FDA 510K and IVDR, it is regulated as a Class B device with a Basic UDI of 150995901AccTGAb3P.

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Properties

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

Other properties (15)

  • Sterile: No
  • Single Use: 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No