Skip to content

ADVIA Centaur aTPOII QC 11206985

by Siemens Healthcare Diagnostics Products Ltd United States EUDAMEDGUDID

Ref 11206985Model IVDR_67_LLB_DUB-C_B_REAG_KIT_aTPOII QC Product code JJXEMDN W0102152211

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686902272VL Basic UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414608587 UDI-DIDate21 Nov 2025ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
ADVIA Centaur aTPOII Quality Control (aTPOII QC) EUDAMED
ADVIA Centaur aTPOII QC GUDID
Generic Name
Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control
Device Name
IVDR_67_LLB_DUB-C_B_REAG_KIT_aTPOII QC
Model / Ref / Catalog
11206985, IVDR_67_LLB_DUB-C_B_REAG_KIT_aTPOII QC
Primary DI / UDI-DI
00630414608587
Basic UDI-DI
0405686902272VL
FDA Product Code
JJX
EMDN Code
W0102152211 Standards and calibrators for autoimmunity
GMDN Term
Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control
Device Class
Class B EUDAMED
Class I GUDID
Regulation Number
862.1660
Market of Registration
Germany
Commercial Distribution
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 & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
Other properties (18)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • FDA UDI 5abeeaa4-e2e7-4ed3-af3c-95a537737c19 36 fields · synced 24 Oct 2026
  • EUDAMED 00630414608587|0405686902272VL 61 fields · synced 24 Oct 2026