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ADVIA Centaur ® IL6 100T Kit 10995080

by Siemens Healthcare Diagnostics Inc.

Ref 10995080Model DX_LS_LEGACY_00630414010434

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

CE IVDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00630414010434 Basic UDI-DI 00630414010434UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414010434 UDI-DI Date22 Jan 2021ListedStatusListed 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  • Withdrawn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/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
ADVIA Centaur Interleukin-6 (IL6) assay EUDAMED
ADVIA Centaur ® IL6 100T Kit GUDID
Generic Name
Interleukin-6 (IL-6) IVD, kit, chemiluminescent immunoassay
Device Name
DX_LS_LEGACY_00630414010434
Model / Ref / Catalog
10995080, DX_LS_LEGACY_00630414010434
Primary DI / UDI-DI
00630414010434
Basic UDI-DI
B-00630414010434
FDA Product Code
QLC
EMDN Code
W01030609 Interleukin 6 (il-6)
GMDN Term
Interleukin-6 (IL-6) IVD, kit, chemiluminescent immunoassay
Device Class
Class IVD General EUDAMED
N GUDID
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
N

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Properties

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

Other properties (16)

  • 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
  • Serial Number: No