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Diazyme DZ168A-CAL

by Diazyme Laboratories, Inc.

Ref DZ168A-CAL

Diazyme DZ168A-CAL is a device classified as IVD General made by Diazyme Laboratories, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-DZ168A-CALPA) and listed in FDA GUDID since 3 Nov 2016 (UDI-DI D-DZ168A-CALPA), 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-DZ168A-CALPA Basic UDI-DI D-DZ168A-CALPAUDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-DZ168A-CALPA UDI-DI Date3 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-DZ168A-CALPA registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI D-DZ168A-CALPA listed 3 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-DZ168A-CALPA
  2. Registered EUDAMED B-DZ168A-CALPA

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  • Withdrawn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
Diazyme Direct Enzymatic HbA1c Calibrators EUDAMED
Diazyme GUDID
Generic name
Glycated haemoglobin (HbA1c) IVD, calibrator
Model / reference
DZ168A-CAL
Primary DI / UDI-DI
D-DZ168A-CALPA EUDAMED
00817089020146 GUDID
Basic UDI-DI
B-DZ168A-CALPA
EMDN code
W0101050302 Calibrators single component (cc)
GMDN term
Glycated haemoglobin (HbA1c) 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-DZ168A-CALPA
GUDID
00817089020146

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-DZ168A-CALPA; FDA GUDID lists 00817089020146), so their flags are not compared.

Related devices

Category: Glycated haemoglobin (HbA1c) IVD, calibrator

Similar devices in this category

Other devices filed under CALIBRATORS SINGLE COMPONENT (CC).

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 (20, all answered No)