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Triage 98100EU

by Quidel Cardiovascular Inc.

Ref 98100EUModel Triage

Triage 98100EU is a device classified as IVD General (EU), Class II (US) made by Quidel Cardiovascular Inc., registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI B-30014613338017) and listed in FDA GUDID since 1 Nov 2018 (UDI-DI 30014613338017), active as of 24 Oct 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-30014613338017 Basic UDI-DI 30014613338017UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613338017 UDI-DI Date1 Nov 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-30014613338017 registered 13 Oct 2026 Active
  • FDA GUDID UDI-DI 30014613338017 listed 1 Nov 2018 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 30014613338017
  2. Registered EUDAMED B-30014613338017

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  • Withdrawn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
Triage D-Dimer EUDAMED
Triage GUDID
Generic name
D-dimer IVD, kit, fluorescent immunoassay
Device name
D-Dimer
Model / Ref / Catalog
98100EU, Triage
Primary DI / UDI-DI
30014613338017
Basic UDI-DI
B-30014613338017
FDA product code
DAP
EMDN code
W0103020803 D-dimer - rt & poc
GMDN term
D-dimer IVD, kit, fluorescent immunoassay
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
Türkiye
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, fluorescent immunoassay

Similar devices in this category

Other devices filed under D-DIMER - RT & POC.

Other devices from Quidel Cardiovascular Inc.

See all devices from Quidel Cardiovascular Inc. →

Properties

  • Single use
  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Near-patient testing
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (13, all answered No)