# Triage 98100

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/triage-98100>
- Manufacturer: [Quidel Cardiovascular Inc.](https://devicerts.com/manufacturers/fda-fei-3013982035) (United States)
- Device class: IVD General (EU IVDD); Class II (US FDA)
- FDA product code: DAP, GHH
- EMDN: W0103020803 D-DIMER - RT & POC
- GMDN: D-dimer IVD, kit, fluorescent immunoassay (61389)

## Registrations and authorizations

- **EUDAMED** · CE/IVDD · European Union · Basic UDI-DI B-30014613338000 · UDI-DI 30014613338000 · registered 2026-10-13 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 30014613338000 · listed 2018-11-01 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K042890 · decision 2004-11-29 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1727-2014 · Class II · terminated · initiated 2014-05-02 · matched through shared submission K042890, may concern other models: 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.
- Z-1932-2012 · Class I · terminated · initiated 2012-05-22 · matched through shared submission K042890, may concern other models: 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.

## Identity

- Trade name: Triage D-Dimer [EUDAMED]; Triage [FDA GUDID (AccessGUDID)]
- Generic name: D-dimer IVD, kit, fluorescent immunoassay [FDA GUDID (AccessGUDID)]
- Device name: D-Dimer [EUDAMED]
- Model / Ref / Catalog: 98100 [EUDAMED, FDA GUDID (AccessGUDID)]; Triage [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 30014613338000 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-30014613338000 [EUDAMED]
- 510(k) Number: K042890 [FDA GUDID (AccessGUDID)]
- FDA product code: DAP [FDA GUDID (AccessGUDID)]
- EMDN code: W0103020803 [EUDAMED]
- GMDN term: D-dimer IVD, kit, fluorescent immunoassay (61389) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IVD General [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 864.7320 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Northern Ireland [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Single use: Yes [FDA GUDID (AccessGUDID)]
- Contains human tissues or cells: Yes [EUDAMED]
- Contains animal tissues or cells: Yes [EUDAMED]
- Reagent: Yes [EUDAMED]
- IVD kit: Yes [EUDAMED]
- Near-patient testing: Yes [EUDAMED]
- Professional testing: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Convenience kit: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Contains substances of microbial origin: No [EUDAMED]
- Self-testing: No [EUDAMED]
- Companion diagnostics: No [EUDAMED]
- IVD instrument: No [EUDAMED]
- New device: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Triage 98100, Quidel Cardiovascular Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/triage-98100 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/triage-98100.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/triage-98100
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.