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Vitros 8642712

by Ortho-Clinical Diagnostics

Ref 8642712Model VITROS

Vitros 8642712 is a buffered sample diluent IVD (EU IVDR Class A; FDA Class I; FDA product code PPM, General purpose reagent) made by Ortho-Clinical Diagnostics, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 10758750005086LB) and listed in FDA GUDID since 12 May 2023 (UDI-DI 10758750005086), 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 Number10758750005086LB Basic UDI-DI 10758750005086UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10758750005086 UDI-DI Date12 May 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 10758750005086LB registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 10758750005086 listed 12 May 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10758750005086
  2. Registered EUDAMED 10758750005086LB

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  • Withdrawn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 A EUDAMED
Vitros GUDID
Generic name
Buffered sample diluent IVD
Model / Ref / Catalog
8642712, VITROS
Primary DI / UDI-DI
10758750005086
Basic UDI-DI
10758750005086LB
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
  • Reagent
  • Professional testing
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)