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Diazyme DZ168C-KY1

by Diazyme Laboratories, Inc.

Ref DZ168C-KY1

Diazyme DZ168C-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-DZ168C-KY1RU), cleared under FDA 510(k) K160762 on 21 Nov 2016 and listed in FDA GUDID since 21 Jul 2020 (UDI-DI D-DZ168C-KY1RU), 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) K160762

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-DZ168C-KY1RU Basic UDI-DI D-DZ168C-KY1RUUDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-DZ168C-KY1RU UDI-DI Date21 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160762 Date21 Nov 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-DZ168C-KY1RU registered 27 Oct 2026 Active
  • FDA 510(k) K160762 decided 21 Nov 2016 Active
  • FDA GUDID UDI-DI D-DZ168C-KY1RU listed 21 Jul 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160762
  2. Listed FDA GUDID D-DZ168C-KY1RU
  3. Registered EUDAMED B-DZ168C-KY1RU

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  • Withdrawn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 Direct HbA1c Assay (Enzymatic, On-Board Lysis) EUDAMED
Diazyme GUDID
Generic name
Glycated haemoglobin (HbA1c) IVD, reagent
Model / reference
DZ168C-KY1
Primary DI / UDI-DI
D-DZ168C-KY1RU EUDAMED
00817089021594 GUDID
Basic UDI-DI
B-DZ168C-KY1RU
510(k) Number
FDA product code
LCP
EMDN code
W01010214 Glycosylated/glycated haemoglobin (cc)
GMDN term
Glycated haemoglobin (HbA1c) IVD, reagent
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
864.7470
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-DZ168C-KY1RU
GUDID
00817089021594
Device classEUDAMED
Class IVD General
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-DZ168C-KY1RU; FDA GUDID lists 00817089021594), 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

Category: Glycated haemoglobin (HbA1c) IVD, reagent

Cleared under the same submission (K160762)

Similar devices in this category

Other devices filed under GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC).

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

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