Skip to content

Diazyme 08896631190

by Diazyme Laboratories, Inc.

Part of a family of 6 devices: see the family page

Ref 08896631190

Diazyme 08896631190 is a kappa/lambda light chain immunoglobulin IVD (EU IVDR Class C) made by Diazyme Laboratories, Inc., registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 0817089022485XW) and listed in FDA GUDID since 21 Jul 2020 (UDI-DI 00817089023017), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0817089022485XW Basic UDI-DI 00817089023017UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817089023017 UDI-DI Date21 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0817089022485XW registered 23 Sep 2026 Active
  • FDA GUDID UDI-DI 00817089023017 listed 21 Jul 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817089023017
  2. Registered EUDAMED 0817089022485XW

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  • Withdrawn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
LFLC (cobas c systems) EUDAMED
Diazyme GUDID
Generic name
Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Device name
LFLC Lambda (λ) Free Light Chains
Model / reference
08896631190
Primary DI / UDI-DI
00817089023017
Basic UDI-DI
0817089022485XW
EMDN code
W0102010109 Kappa and lambda chain
GMDN term
Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
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, kit, nephelometry/turbidimetry

Similar devices in this category

Other devices filed under KAPPA AND LAMBDA CHAIN.

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)