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ADVIA Centaur® CA 15-3® 10312831

by Siemens Healthcare Diagnostics Inc.

Ref 10312831Model IVDR_67_TTN_DUB-C_C_KIT_CA 15-3

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

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 Number0405686901801VL Basic UDI-DI 00630414461328UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414461328 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

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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® CA 15-3®
Generic Name
Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
Device Name
IVDR_67_TTN_DUB-C_c_kit_ca 15-3
Model / Ref / Catalog
10312831, IVDR_67_TTN_DUB-C_C_KIT_CA 15-3, 128535
Primary DI / UDI-DI
00630414461328
Basic UDI-DI
0405686901801VL
Unit of Use DI
00630414003481
510(k) Number
FDA Product Code
MOI
EMDN Code
W0102030102 Cancer antigen 15-3
GMDN Term
Cancer antigen 15-3 (CA15-3) 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

Cleared under the same submission (K012357)

Cleared under the same submission (K192777)

Other devices from Siemens Healthcare Diagnostics Inc.

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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