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Dimension® LIPL CAL 10460278

by Siemens Healthcare Diagnostics Inc.

Ref 10460278Model DX_LS_LEGACY_00842768025228

Dimension LIPL CAL 10460278 (DC56) is a lipase IVD (EU IVDD general IVD; FDA Class II; FDA product code JIT, Calibrator, Secondary) made by Siemens Healthcare Diagnostics Inc., registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI B-00842768025228), cleared under FDA 510(k) K081319 on 4 Aug 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00842768025228), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K081319

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00842768025228 Basic UDI-DI 00842768025228UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768025228 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK081319 Date4 Aug 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00842768025228 registered 23 Sep 2026 Active
  • FDA 510(k) K081319 decided 4 Aug 2008 Active
  • FDA GUDID UDI-DI 00842768025228 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K081319
  2. Listed FDA GUDID 00842768025228
  3. Registered EUDAMED B-00842768025228

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Dimension Lipase Calibrator EUDAMED
Dimension® LIPL CAL GUDID
Generic name
Lipase IVD, calibrator
Device name
DX_LS_LEGACY_00842768025228
Model / Ref / Catalog
10460278, DX_LS_LEGACY_00842768025228, DC56
Primary DI / UDI-DI
00842768025228
Basic UDI-DI
B-00842768025228
510(k) Number
FDA product code
JIT
EMDN code
W0101050302 Calibrators single component (cc)
GMDN term
Lipase IVD, calibrator
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1150
EU registration type
Legacy device (under a directive)
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

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Lipase IVD, calibrator

Similar devices in this category

Other devices filed under CALIBRATORS SINGLE COMPONENT (CC).

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)