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Diazyme DZ062A-CON

by Diazyme Laboratories, Inc.

Ref DZ062A-CON

Diazyme DZ062A-CON is a device classified as IVD General made by Diazyme Laboratories, Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-DZ062A-CONMP) and listed in FDA GUDID since 29 Jul 2020 (UDI-DI D-DZ062A-CONMP), 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-DZ062A-CONMP Basic UDI-DI D-DZ062A-CONMPUDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-DZ062A-CONMP UDI-DI Date29 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-DZ062A-CONMP registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI D-DZ062A-CONMP listed 29 Jul 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-DZ062A-CONMP
  2. Registered EUDAMED B-DZ062A-CONMP

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  • Withdrawn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
N-Acetyl-ß-Glucosaminidase Controls EUDAMED
Diazyme GUDID
Generic name
N-acetyl-beta-D-glucosaminidase (NAG) IVD, control
Model / reference
DZ062A-CON
Primary DI / UDI-DI
D-DZ062A-CONMP EUDAMED
00817089022751 GUDID
Basic UDI-DI
B-DZ062A-CONMP
EMDN code
W0101050201 Enzyme controls
GMDN term
N-acetyl-beta-D-glucosaminidase (NAG) 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-DZ062A-CONMP
GUDID
00817089022751

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-DZ062A-CONMP; FDA GUDID lists 00817089022751), so their flags are not compared.

Related devices

Category: N-acetyl-beta-D-glucosaminidase (NAG) IVD, control

Similar devices in this category

Other devices filed under ENZYME CONTROLS.

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

  • Contains animal tissues or cells
  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)