# Immunalysis 302UR-0060W

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

- Canonical page: <https://devicerts.com/devices/immunalysis-302ur-0060w>
- Manufacturer: [Immunalysis Corporation](https://devicerts.com/manufacturers/immunalysis-corporation) (United States)
- Device class: IVD General (EU IVDD); Class II (US FDA)
- FDA product code: DJG
- EMDN: W0102090123 OXYCODINE
- GMDN: Oxycodone IVD, kit, enzyme immunoassay (EIA) (62306)

## Registrations and authorizations

- **EUDAMED** · CE/IVDD · European Union · Basic UDI-DI B-00840937107744 · UDI-DI 00840937107744 · registered 2026-08-31 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00840937107744 · listed 2016-08-31 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K131168 · decision 2014-01-17 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: Immunalysis [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Oxycodone IVD, kit, enzyme immunoassay (EIA) [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 302UR-0060W [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00840937107744 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-00840937107744 [EUDAMED]
- 510(k) Number: K131168 [FDA GUDID (AccessGUDID)]
- FDA product code: DJG [FDA GUDID (AccessGUDID)]
- EMDN code: W0102090123 [EUDAMED]
- GMDN term: Oxycodone IVD, kit, enzyme immunoassay (EIA) (62306) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IVD General [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 862.3650 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Netherlands [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

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

## Source and citation

- Cite as: Immunalysis 302UR-0060W, Immunalysis Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/immunalysis-302ur-0060w (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/immunalysis-302ur-0060w.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/immunalysis-302ur-0060w
- 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.