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Diazyme DZ135A-CON

by Diazyme Laboratories, Inc.

Ref DZ135A-CON

Diazyme DZ135A-CON is a device classified as IVD General made by Diazyme Laboratories, Inc., registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-DZ135A-CONMW) and listed in FDA GUDID since 3 Nov 2016 (UDI-DI D-DZ135A-CONMW), 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-DZ135A-CONMW Basic UDI-DI D-DZ135A-CONMWUDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-DZ135A-CONMW UDI-DI Date3 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-DZ135A-CONMW registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI D-DZ135A-CONMW listed 3 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-DZ135A-CONMW
  2. Registered EUDAMED B-DZ135A-CONMW

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  • Withdrawn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
Diazyme hs-CRP Control Set EUDAMED
Diazyme GUDID
Generic name
C-reactive protein (CRP) IVD, control
Model / reference
DZ135A-CON
Primary DI / UDI-DI
D-DZ135A-CONMW EUDAMED
00817089020337 GUDID
Basic UDI-DI
B-DZ135A-CONMW
EMDN code
W0102152004 Cardiac marker controls
GMDN term
C-reactive protein (CRP) 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-DZ135A-CONMW
GUDID
00817089020337

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-DZ135A-CONMW; FDA GUDID lists 00817089020337), so their flags are not compared.

Related devices

Category: C-reactive protein (CRP) IVD, control

Similar devices in this category

Other devices filed under CARDIAC MARKER CONTROLS.

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

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