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MassTrak 186010253IVD

by Waters Technologies Corporation

Ref 186010253IVD

MassTrak 186010253IVD is an in vitro diagnostic device (EU IVDD general IVD; FDA Class II; FDA product code JIX, Calibrator, Multi-Analyte Mixture; EMDN category calibrators and standards (clinical chemistry)) made by Waters Technologies Corporation, registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI B-00816776020537) and listed in FDA GUDID since 5 Apr 2022 (UDI-DI 00816776020537), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00816776020537 Basic UDI-DI 00816776020537UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816776020537 UDI-DI Date5 Apr 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00816776020537 registered 2 Sep 2026 Active
  • FDA GUDID UDI-DI 00816776020537 listed 5 Apr 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816776020537
  2. Registered EUDAMED B-00816776020537

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  • Withdrawn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
MassTrak™ Immunosuppressant Internal Standard Set EUDAMED
MassTrak GUDID
Generic name
Multiple immunosuppressant therapeutic drug monitoring IVD, calibrator
Device name
MassTrak™ Immunosuppressants Product Family
Model / Ref / Catalog
186010253IVD
Primary DI / UDI-DI
00816776020537
Basic UDI-DI
B-00816776020537
FDA product code
JIX
EMDN code
W0101050399 Calibrators and standards (clinical chemistry) - other
GMDN term
Multiple immunosuppressant 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
Ireland
GUDID distribution status
In Commercial Distribution

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 immunosuppressant therapeutic drug monitoring IVD, calibrator

Similar devices in this category

Other devices filed under CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER.

Other devices from Waters Technologies Corporation

See all devices from Waters Technologies Corporation →

Properties

  • Contains human tissues or cells
  • Reagent
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)