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IntraStain K2311

by Agilent Technologies Singapore Pte Ltd

Ref K2311Model K231111-2

IntraStain K2311 is a device classified as Class A in the EU and Class I in the US made by Agilent Technologies Singapore Pte Ltd, registered in EUDAMED on 26 May 2026 (Basic UDI-DI 570057P3006P3008A054701S8) and listed in FDA GUDID since 17 Sep 2020 (UDI-DI 05700572004387), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number570057P3006P3008A054701S8 Basic UDI-DI 05700572004387UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05700572004387 UDI-DI Date17 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 570057P3006P3008A054701S8 registered 26 May 2026 Active
  • FDA GUDID UDI-DI 05700572004387 listed 17 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05700572004387
  2. Registered EUDAMED 570057P3006P3008A054701S8

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  • Withdrawn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
IntraStain
Generic name
Specimen stabilization reagent IVD
Model / reference
K2311, K231111-2
Primary DI / UDI-DI
05700572004387
Basic UDI-DI
570057P3006P3008A054701S8
FDA product code
GGK
EMDN code
W0103080599 Auxiliary & supplemental reagents for flow cytometry - other
GMDN term
Specimen stabilization reagent IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.8540
EU registration type
Standard device
EU market of registration
Denmark
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: Specimen stabilization reagent IVD

Similar devices in this category

Other devices filed under AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER.

Other devices from Agilent Technologies Singapore Pte Ltd

See all devices from Agilent Technologies Singapore Pte Ltd →

Properties

  • IVD kit
  • Professional testing
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)