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Diazyme DZ113C-K01

by Diazyme Laboratories, Inc.

Ref DZ113C-K01

Diazyme DZ113C-K01 is an in vitro diagnostic device (EU IVDD general IVD) made by Diazyme Laboratories, Inc., registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-DZ113C-K01HE) and listed in FDA GUDID since 3 Nov 2016 (UDI-DI D-DZ113C-K01HE), 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-DZ113C-K01HE Basic UDI-DI D-DZ113C-K01HEUDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-DZ113C-K01HE UDI-DI Date3 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-DZ113C-K01HE registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI D-DZ113C-K01HE listed 3 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-DZ113C-K01HE
  2. Registered EUDAMED B-DZ113C-K01HE

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  • Withdrawn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 Liquid Stable Potassium Enzymatic Assay EUDAMED
Diazyme GUDID
Generic name
Potassium (K+) IVD, reagent
Model / reference
DZ113C-K01
Primary DI / UDI-DI
D-DZ113C-K01HE EUDAMED
00817089021228 GUDID
Basic UDI-DI
B-DZ113C-K01HE
EMDN code
W01010308 Potassium
GMDN term
Potassium (K+) IVD, reagent
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-DZ113C-K01HE
GUDID
00817089021228

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-DZ113C-K01HE; FDA GUDID lists 00817089021228), so their flags are not compared.

Related devices

Category: Potassium (K+) IVD, reagent

Similar devices in this category

Other devices filed under ELECTROLYTES REAGENTS (EXCLUDING ELECTRODES).

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

  • Contains substances of microbial origin
  • Reagent
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)