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isatuximab CONTROL

by sebia

Ref 4764

isatuximab CONTROL (4764) is a device classified as Class A in the EU and Class I in the US made by Sebia, registered in EUDAMED on 21 Jul 2022 (Basic UDI-DI 3607364764BUFF) and listed in FDA GUDID since 12 Dec 2022 (UDI-DI 03607360047644), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03607360047644 UDI-DI Date12 Dec 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number3607364764BUFF Basic UDI-DI 03607360047644UDI-DIDate21 Jul 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 3607364764BUFF registered 21 Jul 2022 Active
  • FDA GUDID UDI-DI 03607360047644 listed 12 Dec 2022 Listed

Timeline

2 dated events

  1. Registered EUDAMED 3607364764BUFF
  2. Listed FDA GUDID 03607360047644

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  • Withdrawn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

Generic name
Protein electrophoresis IVD, control
Model / Ref / Catalog
4764
Primary DI / UDI-DI
03607360047644
Basic UDI-DI
3607364764BUFF
FDA product code
JJX
EMDN code
W0101050101 Assayed multicomponent controls (cc)
GMDN term
Protein electrophoresis IVD, control
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.1660
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.

Manufacturer details

EUDAMED SRN
FR-MF-000003520

Similar devices in this category

Other devices filed under ASSAYED MULTICOMPONENT CONTROLS (CC).

Other devices from Sebia

See all devices from Sebia →

Properties

  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)