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Diazyme DZ178C-CAL

by Diazyme Laboratories, Inc.

Ref DZ178C-CAL

Diazyme DZ178C-CAL is a device classified as IVD General made by Diazyme Laboratories, Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-DZ178C-CALQH) and listed in FDA GUDID since 21 Jul 2020 (UDI-DI D-DZ178C-CALQH), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-DZ178C-CALQH Basic UDI-DI D-DZ178C-CALQHUDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-DZ178C-CALQH UDI-DI Date21 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-DZ178C-CALQH registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI D-DZ178C-CALQH listed 21 Jul 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-DZ178C-CALQH
  2. Registered EUDAMED B-DZ178C-CALQH

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Myeloperoxidase Calibrator Set EUDAMED
Diazyme GUDID
Generic name
Myeloperoxidase (MPO) IVD, calibrator
Model / reference
DZ178C-CAL
Primary DI / UDI-DI
D-DZ178C-CALQH EUDAMED
00817089022492 GUDID
Basic UDI-DI
B-DZ178C-CALQH
EMDN code
W0102152204 Cardiac marker standards and calibrators
GMDN term
Myeloperoxidase (MPO) IVD, calibrator
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-DZ178C-CALQH
GUDID
00817089022492

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-DZ178C-CALQH; FDA GUDID lists 00817089022492), so their flags are not compared.

Related devices

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