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Atellica IM BR 10995477

by Siemens Healthcare Diagnostics Inc.

Ref 10995477Model IVDR_67_TTN_DUB-C_C_KIT_BR

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

3 ongoing

This device is named in the recall

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 Number0405686901799WS Basic UDI-DI 00630414598048UDI-DIDate17 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414598048 UDI-DI Date27 Dec 2017ListedStatusListed 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

9 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2425-2021 FDA Class II initiated 6 Jul 2021
    • Ongoing Z-2426-2021 FDA Class II initiated 6 Jul 2021
    • Ongoing Z-2424-2021 FDA Class II initiated 6 Jul 2021

    Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers

  • 3 recalls, same reason

    • Terminated Z-1748-2017 FDA Class II initiated 8 Mar 2017
    • Terminated Z-1747-2017 FDA Class II initiated 8 Mar 2017
    • Terminated Z-1749-2017 FDA Class II initiated 8 Mar 2017

    Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems

  • 2 recalls, same reason

    • Terminated Z-0507-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0512-2013 FDA Class II initiated 14 Nov 2012 on shared 510(k) K982680

    Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.

    • Terminated Z-0162-2013 FDA Class II initiated 11 Sep 2012

    BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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
Atellica IM BR 27.29 (BR) EUDAMED
Atellica IM BR GUDID
Generic Name
Cancer antigen 27-29 (CA27-29) IVD, kit, chemiluminescent immunoassay
Device Name
IVDR_67_TTN_DUB-C_c_kit_br
Model / Ref / Catalog
10995477, IVDR_67_TTN_DUB-C_C_KIT_BR
Primary DI / UDI-DI
00630414598048
Basic UDI-DI
0405686901799WS
Unit of Use DI
00630414007359
510(k) Number
FDA Product Code
MOI
EMDN Code
W0102030110 Cancer antigen 27.29
GMDN Term
Cancer antigen 27-29 (CA27-29) IVD, kit, chemiluminescent immunoassay
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
866.6010
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class C
GUDID
Class II

Related devices

Category: Cancer antigen 27-29 (CA27-29) IVD, kit, chemiluminescent immunoassay

Cleared under the same submission (K193489)

Cleared under the same submission (K982680)

Show all (12)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No