Skip to content

ADVIA Centaur aTgII Master Curve Material (aTgII MCM) 11200352

by Siemens Healthcare Diagnostics Products Ltd

Ref 11200352Model IVDR_67_LLB_DUB-C_B_REAG_aTgII MCM

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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/IVDR EUDAMED Number0405686901418VH Basic UDI-DI 00630414245386UDI-DIDate7 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414245386 UDI-DI Date4 Feb 2026ListedStatusListed 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.

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  • Withdrawn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 aTgII Master Curve Material (aTgII MCM)
Generic Name
Thyroglobulin antibody IVD, control
Device Name
IVDR_67_LLB_DUB-C_B_REAG_aTgII MCM
Model / Ref / Catalog
11200352, IVDR_67_LLB_DUB-C_B_REAG_aTgII MCM
Primary DI / UDI-DI
00630414245386
Basic UDI-DI
0405686901418VH
FDA Product Code
JJX
EMDN Code
W0102152011 Controls for autoimmunity
GMDN Term
Thyroglobulin antibody IVD, control
Device Class
Class B 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 B
GUDID
Class I

Other devices from Siemens Healthcare Diagnostics Products Ltd

See all devices from Siemens Healthcare Diagnostics Products Ltd →

Properties

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

Other properties (18)

  • 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
  • Serial Number: No
  • Manufacturing Date: No