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Dimension® NTP CAL 10464529

by Siemens Healthcare Diagnostics Inc.

Ref 10464529Model IVDR_67_GLA_DUB-C_C_REAG_LOCI NTP CAL

Dimension® NTP CAL 10464529 (RC623) is a device classified as Class C in the EU and Class II in the US made by Siemens Healthcare Diagnostics Inc., registered in EUDAMED on 14 Jul 2026 (Basic UDI-DI 0405686901276VM), cleared under FDA 510(k) K082680 on 10 Oct 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00842768026324), active as of 25 Oct 2026.

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

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K082680

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686901276VM Basic UDI-DI 00842768026324UDI-DIDate14 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768026324 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK082680 Date10 Oct 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686901276VM registered 14 Jul 2026 Active
  • FDA 510(k) K082680 decided 10 Oct 2008 Active
  • FDA GUDID UDI-DI 00842768026324 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K082680
  2. Listed FDA GUDID 00842768026324
  3. Registered EUDAMED 0405686901276VM

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Dimension EXL LOCI N-terminal Pro-Brain Natriuretic Peptide calibrator EUDAMED
Dimension® NTP CAL GUDID
Generic name
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator
Device name
IVDR_67_GLA_DUB-C_c_reag_loci Ntp Cal
Model / Ref / Catalog
10464529, IVDR_67_GLA_DUB-C_C_REAG_LOCI NTP CAL, RC623
Primary DI / UDI-DI
00842768026324
Basic UDI-DI
0405686901276VM
510(k) Number
FDA product code
JIT
EMDN code
W0102152204 Cardiac marker standards and calibrators
GMDN term
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator
Device class
Class C EUDAMED
Class II GUDID
Regulation number
862.1150
EU registration type
Standard device
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

Device class is stated on each registry's own scale: Class C 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: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator

Similar devices in this category

Other devices filed under CARDIAC MARKER STANDARDS AND CALIBRATORS.

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Contains latex
  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)