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Diazyme DZ142A-K

by Diazyme Laboratories, Inc.

Ref DZ142A-K

Diazyme DZ142A-K is a device classified as IVD General made by Diazyme Laboratories, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-DZ142A-K8M) and listed in FDA GUDID since 3 Nov 2016 (UDI-DI D-DZ142A-K8M), 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-DZ142A-K8M Basic UDI-DI D-DZ142A-K8MUDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-DZ142A-K8M UDI-DI Date3 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-DZ142A-K8M registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI D-DZ142A-K8M listed 3 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-DZ142A-K8M
  2. Registered EUDAMED B-DZ142A-K8M

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  • Withdrawn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
Apolipoprotein B Assay EUDAMED
Diazyme GUDID
Generic name
Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Model / reference
DZ142A-K
Primary DI / UDI-DI
D-DZ142A-K8M EUDAMED
90817089020002 GUDID
Basic UDI-DI
B-DZ142A-K8M
EMDN code
W0102010403 Apolipoprotein b
GMDN term
Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
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-DZ142A-K8M
GUDID
90817089020002

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-DZ142A-K8M; FDA GUDID lists 90817089020002), so their flags are not compared.

Related devices

Category: Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

Similar devices in this category

Other devices filed under APOLIPOPROTEIN B.

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)