Skip to content

Diazyme DZ888A-CAL

by Diazyme Laboratories, Inc.

Ref DZ888A-CAL

Diazyme DZ888A-CAL is a Class B device made by Diazyme Laboratories, Inc., registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 0817089021655XQ) and listed in FDA GUDID since 27 Jul 2020 (UDI-DI 00817089021655), 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 Number0817089021655XQ Basic UDI-DI 00817089021655UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817089021655 UDI-DI Date27 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0817089021655XQ registered 25 Sep 2026 Active
  • FDA GUDID UDI-DI 00817089021655 listed 27 Jul 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817089021655
  2. Registered EUDAMED 0817089021655XQ

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  • Withdrawn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 EZ Vitamin D Calibrator Set EUDAMED
Diazyme GUDID
Generic name
Multiple form 25-hydroxy Vitamin D IVD, calibrator
Model / reference
DZ888A-CAL
Primary DI / UDI-DI
00817089021655
Basic UDI-DI
0817089021655XQ
EMDN code
W0102152206 Anaemia related/vitamin standards and calibrators
GMDN term
Multiple form 25-hydroxy Vitamin D IVD, calibrator
Device class
Class B
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple form 25-hydroxy Vitamin D IVD, calibrator

Similar devices in this category

Other devices filed under ANAEMIA RELATED/VITAMIN 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)