Skip to content

Plasma Control Bi-Level 0227/XT2

by Chromsystems Instruments & Chemicals GmbH

Ref 0227/XT2

Plasma Control Bi-Level 0227/XT2 is an in vitro diagnostic device (EU IVDD general IVD; FDA Class I; FDA product code LAS, Drug Specific Control Materials; EMDN category specific controls (cc)) made by Chromsystems Instruments & Chemicals GmbH, registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI B-04250317547538) and listed in FDA GUDID since 27 Aug 2020 (UDI-DI 04250317547538), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-04250317547538 Basic UDI-DI 04250317547538UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250317547538 UDI-DI Date27 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250317547538 registered 16 Sep 2026 Active
  • FDA GUDID UDI-DI 04250317547538 listed 27 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250317547538
  2. Registered EUDAMED B-04250317547538

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
MassCheck® Neuroleptics 2/EXTENDED 2 Plasma Control, Bi-Level (I + II) EUDAMED
Plasma Control Bi-Level GUDID
Generic name
Multiple antipsychotic therapeutic drug monitoring IVD, control
Model / Ref / Catalog
0227/XT2
Primary DI / UDI-DI
04250317547538
Basic UDI-DI
B-04250317547538
FDA product code
LAS
EMDN code
W0101050299 Specific controls (cc) - other
GMDN term
Multiple antipsychotic therapeutic drug monitoring IVD, control
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.3280
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class I

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Multiple antipsychotic therapeutic drug monitoring IVD, control

Similar devices in this category

Other devices filed under SPECIFIC CONTROLS (CC) - OTHER.

Other devices from Chromsystems Instruments & Chemicals GmbH

See all devices from Chromsystems Instruments & Chemicals GmbH →

Properties

  • Reagent
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)