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Diazyme DZ568B-BY2

by Diazyme Laboratories, Inc.

Ref DZ568B-BY2

Diazyme DZ568B-BY2 is a homocysteine IVD (EU IVDR Class B; FDA Class II; FDA product code LPS, Urinary Homocystine (Nonquantitative) Test System) made by Diazyme Laboratories, Inc., registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 0817089020948Y3), cleared under FDA 510(k) K071971 on 17 Sep 2007 and listed in FDA GUDID since 3 Nov 2016 (UDI-DI 00817089020955), active as of 22 Oct 2026.

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

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K071971

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0817089020948Y3 Basic UDI-DI 00817089020955UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817089020955 UDI-DI Date3 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK071971 Date17 Sep 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0817089020948Y3 registered 25 Sep 2026 Active
  • FDA 510(k) K071971 decided 17 Sep 2007 Active
  • FDA GUDID UDI-DI 00817089020955 listed 3 Nov 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K071971
  2. Listed FDA GUDID 00817089020955
  3. Registered EUDAMED 0817089020948Y3

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Diazyme Homocysteine 2 Reagent Enzymatic Assay EUDAMED
Diazyme GUDID
Generic name
Homocysteine IVD, reagent
Model / reference
DZ568B-BY2
Primary DI / UDI-DI
00817089020955
Basic UDI-DI
0817089020948Y3
510(k) Number
FDA product code
LPS
EMDN code
W01021307 Homocysteine
GMDN term
Homocysteine IVD, reagent
Device class
Class B EUDAMED
Class II GUDID
Regulation number
862.1377
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class B
GUDID
Class II

Device class is stated on each registry's own scale: Class B 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: Homocysteine IVD, reagent

Cleared under the same submission (K071971)

Similar devices in this category

Other devices filed under HOMOCYSTEINE.

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

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