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Diazyme DZ122A-KY2

by Diazyme Laboratories, Inc.

Ref DZ122A-KY2

Diazyme DZ122A-KY2 is an in vitro diagnostic device (EU IVDD general IVD) made by Diazyme Laboratories, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-DZ122A-KY2LN) and listed in FDA GUDID since 3 Nov 2016 (UDI-DI D-DZ122A-KY2LN), 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-DZ122A-KY2LN Basic UDI-DI D-DZ122A-KY2LNUDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-DZ122A-KY2LN UDI-DI Date3 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-DZ122A-KY2LN registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI D-DZ122A-KY2LN listed 3 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-DZ122A-KY2LN
  2. Registered EUDAMED B-DZ122A-KY2LN

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  • Withdrawn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 Carbon Dioxide Enzymatic Assay EUDAMED
Diazyme GUDID
Generic name
Carbon dioxide (CO2) IVD, kit, spectrophotometry
Model / reference
DZ122A-KY2
Primary DI / UDI-DI
D-DZ122A-KY2LN EUDAMED
00817089021273 GUDID
Basic UDI-DI
B-DZ122A-KY2LN
EMDN code
W01010302 Bicarbonate
GMDN term
Carbon dioxide (CO2) IVD, kit, spectrophotometry
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-DZ122A-KY2LN
GUDID
00817089021273

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-DZ122A-KY2LN; FDA GUDID lists 00817089021273), so their flags are not compared.

Related devices

Category: Carbon dioxide (CO2) IVD, kit, spectrophotometry

Similar devices in this category

Other devices filed under BICARBONATE.

Other devices from Diazyme Laboratories, Inc.

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Properties

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