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ADVIA Centaur® BNP 10309044

by Siemens Healthcare Diagnostics Inc.

Ref 10309044Model IVDR_67_TTN_DUB-C_C_KIT_BNP

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686900805VM Basic UDI-DI 00630414472805UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414472805 UDI-DI Date24 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

6 recalls · 1 ongoing · FDA

    • Ongoing Z-2053-2018 FDA Class II initiated 18 Dec 2017

    In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays.

    • Terminated Z-0229-2015 FDA Class III initiated 6 Oct 2014

    Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label.

  • 2 recalls, same reason

    • Terminated Z-2149-2014 FDA Class II initiated 23 Jun 2014
    • Terminated Z-2150-2014 FDA Class II initiated 23 Jun 2014

    Complaints of failed calibration.

    • Terminated Z-0506-2013 FDA Class II initiated 14 Nov 2012

    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-2313-2012 FDA Class II initiated 25 Jul 2012

    Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays

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
ADVIA Centaur® BNP
Generic Name
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay
Device Name
IVDR_67_TTN_DUB-C_c_kit_bnp
Model / Ref / Catalog
10309044, IVDR_67_TTN_DUB-C_C_KIT_BNP, 2816138
Primary DI / UDI-DI
00630414472805
Basic UDI-DI
0405686900805VM
510(k) Number
FDA Product Code
NBC
EMDN Code
W01021301 Bnp / probnp (including other natriuric peptides)
GMDN Term
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
862.1117
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

Cleared under the same submission (K031038)

Cleared under the same submission (K043228)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

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

Other properties (19)

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