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Triage 98100

by Quidel Cardiovascular Inc.

Ref 98100Model Triage

Triage 98100 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-30014613338000), cleared under FDA 510(k) K042890 on 29 Nov 2004 and listed in FDA GUDID since 1 Nov 2018 (UDI-DI 30014613338000), active as of 25 Oct 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 ongoing

2 closed

Documents

None, self-declared

Class I: no certifier involved

510(k) K042890

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-30014613338000 Basic UDI-DI 30014613338000UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613338000 UDI-DI Date1 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK042890 Date29 Nov 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-30014613338000 registered 13 Oct 2026 Active
  • FDA 510(k) K042890 decided 29 Nov 2004 Active
  • FDA GUDID UDI-DI 30014613338000 listed 1 Nov 2018 Listed

Certificates

0 certificates · EUDAMED

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

Recalls

2 recalls · FDA

    • Terminated Z-1727-2014 FDA Class II initiated 2 May 2014 on shared 510(k) K042890

    Alere initiated this recall because a limited number of Alere Triage D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected devices will either generate an error code (e.g. E4 error), or they may generate an incorrect result.

    • Terminated Z-1932-2012 FDA Class I initiated 22 May 2012 on shared 510(k) K042890

    Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K042890
  2. Recall initiated FDA recalls Z-1932-2012
  3. Recall initiated FDA recalls Z-1727-2014
  4. Listed FDA GUDID 30014613338000
  5. Registered EUDAMED B-30014613338000

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
Triage D-Dimer EUDAMED
Triage GUDID
Generic name
D-dimer IVD, kit, fluorescent immunoassay
Device name
D-Dimer
Model / Ref / Catalog
98100, Triage
Primary DI / UDI-DI
30014613338000
Basic UDI-DI
B-30014613338000
510(k) Number
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
Northern Ireland
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)