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Diazyme DZ169A-CON

by Diazyme Laboratories, Inc.

Ref DZ169A-CON

Diazyme DZ169A-CON is a Class C device made by Diazyme Laboratories, Inc., registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 0817089021716XK) and listed in FDA GUDID since 16 Jul 2020 (UDI-DI 00817089021716), 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 00817089021716UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817089021716 UDI-DI Date16 Jul 2020ListedStatusListed 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 00817089021716 listed 16 Jul 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817089021716
  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  • Withdrawn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
Diazyme Kappa-Lambda FLC Control Set EUDAMED
Diazyme GUDID
Generic name
Kappa/lambda light chain immunoglobulin IVD, control
Device name
Kappa/Lambda Free Light Chain Control Set
Model / reference
DZ169A-CON
Primary DI / UDI-DI
00817089021716
Basic UDI-DI
0817089021716XK
EMDN code
W0102152003 Specific protein controls
GMDN term
Kappa/lambda light chain immunoglobulin IVD, control
Device class
Class C
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Kappa/lambda light chain immunoglobulin IVD, control

Similar devices in this category

Other devices filed under SPECIFIC PROTEIN CONTROLS.

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

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