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Dimension Vista® CHEM 2 CAL 10445170

by Siemens Healthcare Diagnostics Inc.

Ref 10445170Model DX_LS_LEGACY_00842768015793

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

CE IVDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00842768015793 Basic UDI-DI 00842768015793UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768015793 UDI-DI Date24 Sep 2016ListedStatusListed 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-2387-2010 FDA Unclassified (pre-2012) initiated 26 Feb 2010

    There is incorrect barcode information, which can potentially cause the Alert Message "Calibrator Insert Missing" to be displayed.

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  • Withdrawn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
Dimension Vista Chemistry 2 Calibrator EUDAMED
Dimension Vista® CHEM 2 CAL GUDID
Generic Name
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device Name
DX_LS_LEGACY_00842768015793
Model / Ref / Catalog
10445170, DX_LS_LEGACY_00842768015793, KC120
Primary DI / UDI-DI
00842768015793
Basic UDI-DI
B-00842768015793
510(k) Number
FDA Product Code
JIX
EMDN Code
W0101050301 Calibrators multicomponent (cc)
GMDN Term
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
862.1150
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
Class II

Related devices

Category: Multiple-type clinical chemistry analyte profile IVD, calibrator

Other devices from Siemens Healthcare Diagnostics Inc.

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Properties

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

Other properties (19)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No