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VITEK® 2 DENSICHEK® Plus Standards Kit 21255

by Biomerieux, Inc.

Ref 21255

VITEK® 2 DENSICHEK® Plus Standards Kit 21255 is a device classified as Class A in the EU and Class II in the US made by Biomerieux, Inc., registered in EUDAMED on 21 Jul 2026 (Basic UDI-DI 357302BUDI002006T4), cleared under FDA 510(k) K083536 on 11 Sep 2009 and listed in FDA GUDID since 30 Nov 2016 (UDI-DI 03573026222222), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K083536

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number357302BUDI002006T4 Basic UDI-DI 03573026222222UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03573026222222 UDI-DI Date30 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK083536 Date11 Sep 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 357302BUDI002006T4 registered 21 Jul 2026 Active
  • FDA 510(k) K083536 decided 11 Sep 2009 Active
  • FDA GUDID UDI-DI 03573026222222 listed 30 Nov 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K083536
  2. Listed FDA GUDID 03573026222222
  3. Registered EUDAMED 357302BUDI002006T4

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
VITEK® 2 DENSICHEK® Plus Standards Kit
Generic name
Optical laboratory instrument performance standard calibrator/control IVD, reusable
Model / reference
21255
Primary DI / UDI-DI
03573026222222
Basic UDI-DI
357302BUDI002006T4
510(k) Number
FDA product code
LON
EMDN code
W0203010185 Antibiotic susceptibility analysers - consumables
GMDN term
Optical laboratory instrument performance standard calibrator/control IVD, reusable
Device class
Class A EUDAMED
Class II GUDID
Regulation number
866.1645
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 II

Device class is stated on each registry's own scale: Class A 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: Optical laboratory instrument performance standard calibrator/control IVD, reusable

Cleared under the same submission (K083536)

Similar devices in this category

Other devices filed under ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES.

Other devices from Biomerieux, Inc.

See all devices from Biomerieux, Inc. →

Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)