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Diazyme DZ568-CAL

by Diazyme Laboratories, Inc.

Ref DZ568CAL

Diazyme DZ568-CAL is a homocysteine IVD (EU IVDR Class B) made by Diazyme Laboratories, Inc., registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 0817089021464XF) and listed in FDA GUDID since 3 Nov 2016 (UDI-DI 00817089020290), 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 Number0817089021464XF Basic UDI-DI 00817089020290UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817089020290 UDI-DI Date3 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0817089021464XF registered 25 Sep 2026 Active
  • FDA GUDID UDI-DI 00817089020290 listed 3 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817089020290
  2. Registered EUDAMED 0817089021464XF

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  • Withdrawn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
HCY Calibrator EUDAMED
Diazyme GUDID
Generic name
Homocysteine IVD, calibrator
Device name
Diazyme Homocysteine Enzymatic Calibrators
Model / reference
DZ568CAL EUDAMED
DZ568-CAL GUDID
Primary DI / UDI-DI
00817089020290
Basic UDI-DI
0817089021464XF
EMDN code
W0102152204 Cardiac marker standards and calibrators
GMDN term
Homocysteine IVD, calibrator
Device class
Class B
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
Model / referenceEUDAMED
DZ568CAL
GUDID
DZ568-CAL

Related devices

Category: Homocysteine IVD, calibrator

Similar devices in this category

Other devices filed under CARDIAC MARKER STANDARDS AND CALIBRATORS.

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)