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ADVIA Centaur® T3/T4/VB12 Ancillary Reagent 10319315

by Siemens Healthcare Diagnostics Inc.

Ref 10319315Model IVDR_67_TTN_DUB-C_B_REAG_T3/T4/VB12 Ancillary Reagent

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 Number0405686901772W6 Basic UDI-DI 00630414175379UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414175379 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  • Withdrawn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® T3/T4/VB12 Ancillary Reagent
Generic Name
Multiple thyroid marker IVD, reagent
Device Name
IVDR_67_TTN_DUB-C_B_REAG_T3/T4/VB12 Ancillary Reagent
Model / Ref / Catalog
10319315, IVDR_67_TTN_DUB-C_B_REAG_T3/T4/VB12 Ancillary Reagent, 110328
Primary DI / UDI-DI
00630414175379
Basic UDI-DI
0405686901772W6
Unit of Use DI
00630414003542
510(k) Number
FDA Product Code
CDP
EMDN Code
W01029003 Buffers (unassignable), supplem. reagents, etc (ic)
GMDN Term
Multiple thyroid marker IVD, reagent
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
862.1710
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class II

Related devices

Category: Multiple thyroid marker IVD, reagent

Cleared under the same submission (K913646)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

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

Other properties (20)

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