# Plasma Control Bi-Level 0227/XT2

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

- Canonical page: <https://devicerts.com/devices/plasma-control-bi-level-0227-xt2>
- Manufacturer: [Chromsystems Instruments & Chemicals GmbH](https://devicerts.com/manufacturers/chromsystems-instruments-and-chemicals-gmbh) (FDA registration: Germany)
- Device class: IVD General (EU IVDD); Class I (US FDA)
- FDA product code: LAS
- EMDN: W0101050299 SPECIFIC CONTROLS (CC) - OTHER
- GMDN: Multiple antipsychotic therapeutic drug monitoring IVD, control (65020)

## Registrations and authorizations

- **EUDAMED** · CE/IVDD · European Union · Basic UDI-DI B-04250317547538 · UDI-DI 04250317547538 · registered 2026-09-16 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 04250317547538 · listed 2020-08-27 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: MassCheck® Neuroleptics 2/EXTENDED 2 Plasma Control, Bi-Level (I + II) [EUDAMED]; Plasma Control Bi-Level [FDA GUDID (AccessGUDID)]
- Generic name: Multiple antipsychotic therapeutic drug monitoring IVD, control [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 0227/XT2 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 04250317547538 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-04250317547538 [EUDAMED]
- FDA product code: LAS [FDA GUDID (AccessGUDID)]
- EMDN code: W0101050299 [EUDAMED]
- GMDN term: Multiple antipsychotic therapeutic drug monitoring IVD, control (65020) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IVD General [EUDAMED]; Class I [FDA GUDID (AccessGUDID)]
- Regulation number: 862.3280 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Reagent: Yes [EUDAMED]
- Professional testing: Yes [EUDAMED]
- Premarket exempt: 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 animal tissues or cells: No [EUDAMED]
- Contains substances of microbial origin: 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)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Plasma Control Bi-Level 0227/XT2, Chromsystems Instruments & Chemicals GmbH. deviCERTS medical device catalogue. https://devicerts.com/devices/plasma-control-bi-level-0227-xt2 (data as of 2026-11-15).
- 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: 2026-11-15
- JSON: <https://devicerts.com/devices/plasma-control-bi-level-0227-xt2.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/plasma-control-bi-level-0227-xt2
- 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.