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Diazyme DZ179A-K

by Diazyme Laboratories, Inc.

Ref DZ179A-K

Diazyme DZ179A-K is a D-dimer IVD (EU IVDD general IVD; FDA Class II; FDA product code GHH, Fibrin Split Products) made by Diazyme Laboratories, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-DZ179A-KB7), cleared under FDA 510(k) K112120 on 24 Jan 2013 and listed in FDA GUDID since 3 Nov 2016 (UDI-DI D-DZ179A-KB7), active as of 7 Nov 2026.

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

CE IVDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K112120

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-DZ179A-KB7 Basic UDI-DI D-DZ179A-KB7UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-DZ179A-KB7 UDI-DI Date3 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK112120 Date24 Jan 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-DZ179A-KB7 registered 27 Oct 2026 Active
  • FDA 510(k) K112120 decided 24 Jan 2013 Active
  • FDA GUDID UDI-DI D-DZ179A-KB7 listed 3 Nov 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K112120
  2. Listed FDA GUDID D-DZ179A-KB7
  3. Registered EUDAMED B-DZ179A-KB7

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Diazyme D-Dimer Assay EUDAMED
Diazyme GUDID
Generic name
D-dimer IVD, kit, agglutination
Model / reference
DZ179A-K
Primary DI / UDI-DI
D-DZ179A-KB7 EUDAMED
00817089020528 GUDID
Basic UDI-DI
B-DZ179A-KB7
510(k) Number
FDA product code
GHH
EMDN code
W0103020503 D-dimer
GMDN term
D-dimer IVD, kit, agglutination
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
864.7320
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-DZ179A-KB7
GUDID
00817089020528
Device classEUDAMED
Class IVD General
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-DZ179A-KB7; FDA GUDID lists 00817089020528), so their flags are not compared. Device class is stated on each registry's own scale: Class IVD General 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: D-dimer IVD, kit, agglutination

Cleared under the same submission (K112120)

Similar devices in this category

Other devices filed under D-DIMER.

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

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