# Axis-Shield

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

- Canonical page: <https://devicerts.com/devices/axis-shield-2r10-02>
- Manufacturer: [Axis-Shield Diagnostics Ltd](https://devicerts.com/manufacturers/axis-shield-diagnostics-limited) (United Kingdom)
- Device class: Class C (EU IVDR)
- EMDN: W0102152204 CARDIAC MARKER STANDARDS AND CALIBRATORS

## Registrations and authorizations

- **EUDAMED** · CE/IVDR · European Union · Basic UDI-DI 50558454NTP0010M4 · UDI-DI 05055845400510 · registered 2026-08-20 · status: Active

## Recalls

No recall on record.

## Identity

- Device name: Alere NT-proBNP for ARCHITECT Calibrator Kit [EUDAMED]
- Model / reference: 2R10-02 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 05055845400510 [EUDAMED]
- Basic UDI-DI: 50558454NTP0010M4 [EUDAMED]
- EMDN code: W0102152204 [EUDAMED]

## Classification

- Device class: Class C [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Ireland [EUDAMED]

## Properties

- Contains substances of microbial origin: Yes [EUDAMED]
- IVD kit: Yes [EUDAMED]
- Professional testing: Yes [EUDAMED]
- Supplied sterile: No [EUDAMED]
- Sterilise before use: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Reagent: No [EUDAMED]
- Self-testing: No [EUDAMED]
- Near-patient testing: No [EUDAMED]
- Companion diagnostics: No [EUDAMED]
- IVD instrument: No [EUDAMED]
- New device: No [EUDAMED]

## Source and citation

- Cite as: Axis-Shield, Axis-Shield Diagnostics Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/axis-shield-2r10-02 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/axis-shield-2r10-02.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/axis-shield-2r10-02
- 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.