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D-Di Test® 00454

by Diagnostica Stago

Ref 00454

D-Di Test 00454 is a D-dimer IVD (EU IVDD general IVD; FDA Class II; FDA product code GHH, Fibrin Split Products) made by Diagnostica Stago, registered in EUDAMED on 16 Jul 2026 (Basic UDI-DI B-03607450004540), cleared under FDA 510(k) K890399 on 7 Feb 1989 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 03607450004540), active as of 12 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 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K890399

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-03607450004540 Basic UDI-DI 03607450004540UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03607450004540 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK890399 Date7 Feb 1989DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03607450004540 registered 16 Jul 2026 Active
  • FDA 510(k) K890399 decided 7 Feb 1989 Active
  • FDA GUDID UDI-DI 03607450004540 listed 15 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K890399
  2. Listed FDA GUDID 03607450004540
  3. Registered EUDAMED B-03607450004540

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  • Withdrawn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
D-Di Test®
Generic name
D-dimer IVD, kit, agglutination
Model / reference
00454
Primary DI / UDI-DI
03607450004540
Basic UDI-DI
B-03607450004540
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
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

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

Similar devices in this category

Other devices filed under D-DIMER.

Other devices from Diagnostica Stago

See all devices from Diagnostica Stago →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (14, all answered No)