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N FLC Control SL2 10482442

by Siemens Healthcare Diagnostics Products Ltd

Ref 10482442Model IVDR_27_MAR EB_C_PROF_REAG_N_FLC_Con_SL

N FLC Control SL2 10482442 (OPJF03) is a device classified as Class C in the EU and Class II in the US made by Siemens Healthcare Diagnostics Products Ltd, registered in EUDAMED on 19 Jun 2026 (Basic UDI-DI 0405686900182V4), cleared under FDA 510(k) K171742 on 17 Nov 2017 and listed in FDA GUDID since 20 Feb 2018 (UDI-DI 00842768031465), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171742

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686900182V4 Basic UDI-DI 00842768031465UDI-DIDate19 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768031465 UDI-DI Date20 Feb 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171742 Date17 Nov 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686900182V4 registered 19 Jun 2026 Active
  • FDA 510(k) K171742 decided 17 Nov 2017 Active
  • FDA GUDID UDI-DI 00842768031465 listed 20 Feb 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171742
  2. Listed FDA GUDID 00842768031465
  3. Registered EUDAMED 0405686900182V4

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  • Withdrawn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
N FLC Control SL2
Generic name
Kappa/lambda light chain immunoglobulin IVD, control
Device name
IVDR_27_MAR EB_C_PROF_REAG_N_FLC_Con_SL
Model / Ref / Catalog
10482442, IVDR_27_MAR EB_C_PROF_REAG_N_FLC_Con_SL, OPJF03
Primary DI / UDI-DI
00842768031465
Basic UDI-DI
0405686900182V4
Unit of use DI
04056869221960
510(k) Number
FDA product code
DFH
EMDN code
W0102152005 Tumour marker controls
GMDN term
Kappa/lambda light chain immunoglobulin IVD, control
Device class
Class C EUDAMED
Class II GUDID
Regulation number
866.5550
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: Kappa/lambda light chain immunoglobulin IVD, control

Cleared under the same submission (K171742)

and 3 more cleared under K171742

Similar devices in this category

Other devices filed under TUMOUR MARKER CONTROLS.

Other devices from Siemens Healthcare Diagnostics Products Ltd

See all devices from Siemens Healthcare Diagnostics Products Ltd →

Properties

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