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Diazyme 06U9510

by Diazyme Laboratories, Inc.

Ref 06U9510

Diazyme 06U9510 is a device classified as Class C in the EU and Class II in the US made by Diazyme Laboratories, Inc., registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 0817089021716XK) and listed in FDA GUDID since 22 Oct 2025 (UDI-DI 00817089023512), active as of 25 Oct 2026.

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

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0817089021716XK Basic UDI-DI 00817089023512UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817089023512 UDI-DI Date22 Oct 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0817089021716XK registered 23 Sep 2026 Active
  • FDA GUDID UDI-DI 00817089023512 listed 22 Oct 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817089023512
  2. Registered EUDAMED 0817089021716XK

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  • Withdrawn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
Kappa Lambda FLC Control Set (2x 3ml) EUDAMED
Diazyme GUDID
Generic name
Kappa/lambda light chain immunoglobulin IVD, control
Device name
Kappa/Lambda Free Light Chain Control Set
Model / reference
06U9510
Primary DI / UDI-DI
00817089023512
Basic UDI-DI
0817089021716XK
FDA product code
DFH, DEH
EMDN code
W0102152003 Specific protein 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.

Similar devices in this category

Other devices filed under SPECIFIC PROTEIN CONTROLS.

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Properties

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