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Elecsys Anti-Tg 09745602190

by Roche Diagnostics Corp.

Ref 09745602190

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 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number761333603328AX Basic UDI-DI 07613336217764UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613336217764 UDI-DI Date7 Aug 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 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  • Withdrawn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
Elecsys Anti-Tg
Generic Name
Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
09745602190
Primary DI / UDI-DI
07613336217764
Basic UDI-DI
761333603328AX
510(k) Number
FDA Product Code
JZO
EMDN Code
W0102100303 Thyroglobulin autoantibody
GMDN Term
Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
866.5870
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

Cleared under the same submission (K222610)

Other devices from Roche Diagnostics Corp.

See all devices from Roche Diagnostics Corp. →

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No