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Diazyme DZ122A-KY1

by Diazyme Laboratories, Inc.

Ref DZ122A-KY1

Diazyme DZ122A-KY1 is a device classified as IVD General (EU), Class II (US) made by Diazyme Laboratories, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-DZ122A-KY1LL), cleared under FDA 510(k) K060619 on 21 Jul 2006 and listed in FDA GUDID since 21 Jan 2026 (UDI-DI D-DZ122A-KY1LL), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K060619

FDA submission, from GUDID

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-KY1LL Basic UDI-DI D-DZ122A-KY1LLUDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-DZ122A-KY1LL UDI-DI Date21 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK060619 Date21 Jul 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-DZ122A-KY1LL registered 27 Oct 2026 Active
  • FDA 510(k) K060619 decided 21 Jul 2006 Active
  • FDA GUDID UDI-DI D-DZ122A-KY1LL listed 21 Jan 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K060619
  2. Listed FDA GUDID D-DZ122A-KY1LL
  3. Registered EUDAMED B-DZ122A-KY1LL

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Diazyme Carbon Dioxide Enzymatic Assay EUDAMED
Diazyme GUDID
Generic name
Carbon dioxide (CO2) IVD, kit, spectrophotometry
Model / reference
DZ122A-KY1
Primary DI / UDI-DI
D-DZ122A-KY1LL EUDAMED
00817089023048 GUDID
Basic UDI-DI
B-DZ122A-KY1LL
510(k) Number
FDA product code
KHS
EMDN code
W01010302 Bicarbonate
GMDN term
Carbon dioxide (CO2) IVD, kit, spectrophotometry
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1160
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-DZ122A-KY1LL
GUDID
00817089023048
Device classEUDAMED
Class IVD General
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-DZ122A-KY1LL; FDA GUDID lists 00817089023048), so their flags are not compared. Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Cleared under the same submission (K060619)

Similar devices in this category

Other devices filed under BICARBONATE.

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

  • Contains substances of microbial origin
  • Reagent
  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)