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Diazyme DZ568A-K03

by Diazyme Laboratories, Inc.

Ref DZ568A-K03

Diazyme DZ568A-K03 is a homocysteine IVD (EU IVDR Class B) made by Diazyme Laboratories, Inc., registered in EUDAMED on 8 Oct 2026 (Basic UDI-DI 0817089020807XG) and listed in FDA GUDID since 3 Nov 2016 (UDI-DI 00817089020870), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0817089020807XG Basic UDI-DI 00817089020870UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817089020870 UDI-DI Date3 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0817089020807XG registered 8 Oct 2026 Active
  • FDA GUDID UDI-DI 00817089020870 listed 3 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817089020870
  2. Registered EUDAMED 0817089020807XG

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  • Withdrawn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 Homocysteine Enzymatic Assay Kit EUDAMED
Diazyme GUDID
Generic name
Homocysteine IVD, reagent
Model / reference
DZ568A-K03
Primary DI / UDI-DI
00817089020870
Basic UDI-DI
0817089020807XG
EMDN code
W01021307 Homocysteine
GMDN term
Homocysteine IVD, reagent
Device class
Class B
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Homocysteine IVD, reagent

Similar devices in this category

Other devices filed under HOMOCYSTEINE.

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

  • Contains substances of microbial origin
  • Reagent
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)