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Vitros 8321200

by Ortho-Clinical Diagnostics

Ref 8321200Model VITROS

Vitros 8321200 is a device classified as Class A in the EU and Class I in the US made by Ortho-Clinical Diagnostics, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 10758750004744LP) and listed in FDA GUDID since 16 May 2020 (UDI-DI 10758750004744), active as of 7 Nov 2026.

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

CE IVDR

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number10758750004744LP Basic UDI-DI 10758750004744UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10758750004744 UDI-DI Date16 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 10758750004744LP registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 10758750004744 listed 16 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10758750004744
  2. Registered EUDAMED 10758750004744LP

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
High Sample Diluent B Reagent Pack EUDAMED
Vitros GUDID
Generic name
Buffered sample diluent IVD
Model / Ref / Catalog
8321200, VITROS
Primary DI / UDI-DI
10758750004744
Basic UDI-DI
10758750004744LP
FDA product code
PPM
EMDN code
W0201020185 Automated immunochemistry analysers - consumables
GMDN term
Buffered sample diluent IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.4010
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A 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: Buffered sample diluent IVD

Similar devices in this category

Other devices filed under AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES.

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Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)