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Plasma Calibrator Set 61028

by Chromsystems Instruments & Chemicals GmbH

Ref 61028

Plasma Calibrator Set 61028 is a multiple-therapy therapeutic drug monitoring IVD (EU IVDD general IVD; FDA Class II; FDA product code JIX, Calibrator, Multi-Analyte Mixture) made by Chromsystems Instruments & Chemicals GmbH, registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI B-04250317541765) and listed in FDA GUDID since 22 Mar 2019 (UDI-DI 04250317541765), 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-04250317541765 Basic UDI-DI 04250317541765UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250317541765 UDI-DI Date22 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250317541765 registered 9 Sep 2026 Active
  • FDA GUDID UDI-DI 04250317541765 listed 22 Mar 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250317541765
  2. Registered EUDAMED B-04250317541765

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  • Withdrawn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
3PLUS1® Multilevel Plasma Calibrator Set EUDAMED
Plasma Calibrator Set GUDID
Generic name
Multiple-therapy therapeutic drug monitoring IVD, calibrator
Model / Ref / Catalog
61028
Primary DI / UDI-DI
04250317541765
Basic UDI-DI
B-04250317541765
FDA product code
JIX
EMDN code
W0101050301 Calibrators multicomponent (cc)
GMDN term
Multiple-therapy therapeutic drug monitoring IVD, calibrator
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1150
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

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

Related devices

Category: Multiple-therapy therapeutic drug monitoring IVD, calibrator

Similar devices in this category

Other devices filed under CALIBRATORS MULTICOMPONENT (CC).

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)