# Multichem WBT 04S16-10

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

- Canonical page: <https://devicerts.com/devices/multichem-wbt-04s16-10>
- Manufacturer: [Techno-Path Manufacturing](https://devicerts.com/manufacturers/techno-path-manufacturing) (Ireland)
- Device class: Class C (EU IVDR); Class I (US FDA)
- FDA product code: JJY, DIF, OHQ
- EMDN: W0102080699 IMMUNOSUPPRESSANT TDM - OTHER
- GMDN: Multiple-type clinical chemistry analyte profile IVD, control (47869)

## Registrations and authorizations

- **EUDAMED** · CE/IVDR · European Union · Basic UDI-DI 539152344IMMA029C · UDI-DI 05391523441889 · registered 2026-08-10 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 05391523441889 · listed 2022-09-15 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: Multichem WBT [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Multiple-type clinical chemistry analyte profile IVD, control [FDA GUDID (AccessGUDID)]
- Model / reference: 04S16-10 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 05391523441889 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 539152344IMMA029C [EUDAMED]
- FDA product code: JJY [FDA GUDID (AccessGUDID)]; DIF [FDA GUDID (AccessGUDID)]; OHQ [FDA GUDID (AccessGUDID)]
- EMDN code: W0102080699 [EUDAMED]
- GMDN term: Multiple-type clinical chemistry analyte profile IVD, control (47869) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class C [EUDAMED]; Class I [FDA GUDID (AccessGUDID)]
- Regulation number: 862.1660 [FDA GUDID (AccessGUDID)]; 862.3280 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Ireland [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Contains human tissues or cells: Yes [EUDAMED]
- Professional testing: Yes [EUDAMED]
- 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 animal tissues or cells: No [EUDAMED]
- Contains substances of microbial origin: No [EUDAMED]
- Reagent: No [EUDAMED]
- IVD kit: 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)]
- Convenience kit: 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: Multichem WBT 04S16-10, Techno-Path Manufacturing. deviCERTS medical device catalogue. https://devicerts.com/devices/multichem-wbt-04s16-10 (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: 2026-10-24
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/multichem-wbt-04s16-10.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/multichem-wbt-04s16-10
- 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.