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ADVIA Centaur®Active B12 10995091

by Siemens Healthcare Diagnostics Inc.

Ref 10995091Model DX_LS_LEGACY_00630414603124

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

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00630414603124 Basic UDI-DI 00630414603124UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414603124 UDI-DI Date24 Sep 2020ListedStatusListed 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 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
ADVIA Centaur Systems Active-B12 (AB12) Quality Control EUDAMED
ADVIA Centaur®Active B12 GUDID
Generic Name
Holotranscobalamin (holoTC) IVD, control
Device Name
DX_LS_LEGACY_00630414603124
Model / Ref / Catalog
10995091, DX_LS_LEGACY_00630414603124
Primary DI / UDI-DI
00630414603124
Basic UDI-DI
B-00630414603124
510(k) Number
FDA Product Code
JJX
EMDN Code
W0102152006 Anaemia related/vitamin controls
GMDN Term
Holotranscobalamin (holoTC) IVD, control
Device Class
Class IVD General EUDAMED
Class I GUDID
Regulation Number
862.1660
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
GUDID
Class I

Related devices

Category: Holotranscobalamin (holoTC) IVD, control

Cleared under the same submission (K160757)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

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

Other properties (17)

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