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Diazyme DZ179A-CAL

by Diazyme Laboratories, Inc.

Ref DZ179A-CAL

Diazyme DZ179A-CAL is a D-dimer IVD (EU IVDD general IVD; FDA Class II) made by Diazyme Laboratories, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-DZ179A-CALQ8), cleared under FDA 510(k) K112120 on 24 Jan 2013 and listed in FDA GUDID since 3 Nov 2016 (UDI-DI D-DZ179A-CALQ8), 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-CALQ8 Basic UDI-DI D-DZ179A-CALQ8UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-DZ179A-CALQ8 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-CALQ8 registered 27 Oct 2026 Active
  • FDA 510(k) K112120 decided 24 Jan 2013 Active
  • FDA GUDID UDI-DI D-DZ179A-CALQ8 listed 3 Nov 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K112120
  2. Listed FDA GUDID D-DZ179A-CALQ8
  3. Registered EUDAMED B-DZ179A-CALQ8

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  • Withdrawn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 Calibrator Set EUDAMED
Diazyme GUDID
Generic name
D-dimer IVD, calibrator
Model / reference
DZ179A-CAL
Primary DI / UDI-DI
D-DZ179A-CALQ8 EUDAMED
00817089020535 GUDID
Basic UDI-DI
B-DZ179A-CALQ8
510(k) Number
FDA product code
JIT, GHH
EMDN code
W0103020701 Calibration plasma for haemostasis
GMDN term
D-dimer IVD, calibrator
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1150, 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-CALQ8
GUDID
00817089020535
Device classEUDAMED
Class IVD General
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-DZ179A-CALQ8; FDA GUDID lists 00817089020535), 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, calibrator

Cleared under the same submission (K112120)

Similar devices in this category

Other devices filed under CALIBRATION PLASMA FOR HAEMOSTASIS.

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)