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Diazyme DZ153A-CON

by Diazyme Laboratories, Inc.

Ref DZ153A-CON

Diazyme DZ153A-CON is a Class B device made by Diazyme Laboratories, Inc., registered in EUDAMED on 24 Jul 2026 (Basic UDI-DI 0817089023154XB) and listed in FDA GUDID since 29 Nov 2023 (UDI-DI 00817089023154), 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 Number0817089023154XB Basic UDI-DI 00817089023154UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817089023154 UDI-DI Date29 Nov 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0817089023154XB registered 24 Jul 2026 Active
  • FDA GUDID UDI-DI 00817089023154 listed 29 Nov 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817089023154
  2. Registered EUDAMED 0817089023154XB

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  • Withdrawn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
β-Hydroxybutyrate (BHB) Control Kit EUDAMED
Diazyme GUDID
Generic name
Beta-hydroxybutyrate IVD, control
Device name
β-Hydroxybutyrate Control Set
Model / reference
DZ153A-CON
Primary DI / UDI-DI
00817089023154
Basic UDI-DI
0817089023154XB
EMDN code
W0101050201 Enzyme controls
GMDN term
Beta-hydroxybutyrate IVD, control
Device class
Class B
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Beta-hydroxybutyrate IVD, control

Similar devices in this category

Other devices filed under ENZYME CONTROLS.

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)