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Atellica IM Herpes-2 IgG 10733033

by Siemens Healthcare Diagnostics Inc.

Ref 10733033Model IVDR_67_TTN_DUB-C_C_KIT_HSV2

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

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 Number0405686901816VZ Basic UDI-DI 00842768022807UDI-DIDate17 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768022807 UDI-DI Date28 Oct 2022ListedStatusListed 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

1 recall · FDA

    • Terminated Z-1274-2021 FDA Class II initiated 8 Feb 2021

    Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequency (Interval) Failures on the ADVIA Centaur XP System and ADVIA Centaur XPT System.

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  • Withdrawn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
Atellica IM Herpes-2 IgG (HSV2) EUDAMED
Atellica IM Herpes-2 IgG GUDID
Generic Name
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Device Name
IVDR_67_TTN_DUB-C_C_KIT_HSV2
Model / Ref / Catalog
10733033, IVDR_67_TTN_DUB-C_C_KIT_HSV2
Primary DI / UDI-DI
00842768022807
Basic UDI-DI
0405686901816VZ
510(k) Number
FDA Product Code
MYF
EMDN Code
W0105040309 Hsv 2 igg
GMDN Term
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
866.3305
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class C
GUDID
Class II

Related devices

Category: Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Cleared under the same submission (K181334)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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