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ADVIA Centaur® CKMB 10326496

by Siemens Healthcare Diagnostics Inc.

Ref 10326496Model IVDR_67_TTN_DUB-C_C_KIT_CKMB

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

5 closed

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 Number0405686901804VS Basic UDI-DI 00630414177441UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414177441 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

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0114-2019 FDA Class II initiated 24 Jul 2018
    • Terminated Z-0117-2019 FDA Class II initiated 24 Jul 2018
    • Terminated Z-0113-2019 FDA Class II initiated 24 Jul 2018
    • Terminated Z-0116-2019 FDA Class II initiated 24 Jul 2018
    • Terminated Z-0115-2019 FDA Class II initiated 24 Jul 2018

    A potential bias was identified with certain kits compared to the internal standards.

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  • Withdrawn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® CKMB
Generic Name
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
Device Name
IVDR_67_TTN_DUB-C_c_kit_ckmb
Model / Ref / Catalog
10326496, IVDR_67_TTN_DUB-C_C_KIT_CKMB, 110774
Primary DI / UDI-DI
00630414177441
Basic UDI-DI
0405686901804VS
Unit of Use DI
00630414003627
510(k) Number
FDA Product Code
JHS
EMDN Code
W01021311 Creatine kinase - mb mass (ic)
GMDN Term
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
862.1215
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 (K962126)

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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