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Diazyme DZ138A-CON

by Diazyme Laboratories, Inc.

Ref DZ138A-CON

Diazyme DZ138A-CON is a multiple lipid analyte IVD (EU IVDD general IVD) made by Diazyme Laboratories, Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-DZ138A-CONP5) and listed in FDA GUDID since 3 Nov 2016 (UDI-DI D-DZ138A-CONP5), 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-DZ138A-CONP5 Basic UDI-DI D-DZ138A-CONP5UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-DZ138A-CONP5 UDI-DI Date3 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-DZ138A-CONP5 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI D-DZ138A-CONP5 listed 3 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-DZ138A-CONP5
  2. Registered EUDAMED B-DZ138A-CONP5

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  • Withdrawn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
Multi-Analyte Lipid Control Set EUDAMED
Diazyme GUDID
Generic name
Multiple lipid analyte IVD, control
Model / reference
DZ138A-CON
Primary DI / UDI-DI
D-DZ138A-CONP5 EUDAMED
00817089020023 GUDID
Basic UDI-DI
B-DZ138A-CONP5
EMDN code
W0101050202 Lipid controls
GMDN term
Multiple lipid analyte IVD, control
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-DZ138A-CONP5
GUDID
00817089020023

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-DZ138A-CONP5; FDA GUDID lists 00817089020023), so their flags are not compared.

Related devices

Category: Multiple lipid analyte IVD, control

Similar devices in this category

Other devices filed under LIPID CONTROLS.

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

  • Contains human tissues or cells
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)