Skip to content

Diagnostic BioSystems K089-HL

by Diagnostic BioSystems

Ref K089-HLModel Antigen Retrieval Buffers

Diagnostic BioSystems K089-HL is a device classified as Class A in the EU and Class I in the US made by Diagnostic BioSystems, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 08464050K089HLZE) and listed in FDA GUDID since 8 Jun 2026 (UDI-DI 00846405022281), 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number08464050K089HLZE Basic UDI-DI 00846405022281UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846405022281 UDI-DI Date8 Jun 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08464050K089HLZE registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 00846405022281 listed 8 Jun 2026 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00846405022281
  2. Registered EUDAMED 08464050K089HLZE

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  • Withdrawn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
Ready to use Citrate Buffer for Heat Induced Epitope Recovery, pH 6.0 (CA2) EUDAMED
Diagnostic BioSystems GUDID
Generic name
Saline sodium citrate buffer IVD
Model / reference
K089-HL, Antigen Retrieval Buffers
Primary DI / UDI-DI
00846405022281
Basic UDI-DI
08464050K089HLZE
FDA product code
JCC
EMDN code
W01029003 Buffers (unassignable), supplem. reagents, etc (ic)
GMDN term
Saline sodium citrate buffer IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.4010
EU registration type
Standard device
EU market of registration
Netherlands
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.

Similar devices in this category

Other devices filed under BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC).

Other devices from Diagnostic BioSystems

See all devices from Diagnostic BioSystems →

Properties

  • Single use
  • Reagent
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)