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Diluent solution

by Diamond Diagnostics Inc 8 variants

Ref DA-S640D

Diluent solution (DA-S640D) is a buffered sample diluent IVD (EU IVDR Class A) made by DIAMOND DIAGNOSTICS Inc, registered in EUDAMED on 15 May 2024 (Basic UDI-DI 081140301DAS640DK4) and listed in FDA GUDID since 13 Jun 2023 (UDI-DI 00811403014224), 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
European UnionCE/IVDR EUDAMED Number081140301DAS640DK4 Basic UDI-DI 00811403014224UDI-DIDate15 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00811403014224 UDI-DI Date13 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081140301DAS640DK4 registered 15 May 2024 Active
  • FDA GUDID UDI-DI 00811403014224 listed 13 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00811403014224
  2. Registered EUDAMED 081140301DAS640DK4

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  • Withdrawn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
Diluent solution EUDAMED
Quick IMT Diluent Check GUDID
Generic name
Buffered sample diluent IVD
Device name
Dilution Check Solution IMT
Model / reference
DA-S640D
Primary DI / UDI-DI
00811403014224
Basic UDI-DI
081140301DAS640DK4
EMDN code
W01019099 Clinical chemistry reagents - other
GMDN term
Buffered sample diluent IVD
Device class
Class A
EU registration type
Standard device
EU market of registration
Hungary
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000035435
Authorised representative
Diamond Diagnostics Inc. Magyarországi Fióktelepe HU-AR-000034351

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Similar devices in this category

Other devices filed under CLINICAL CHEMISTRY REAGENTS - OTHER.

Other devices from DIAMOND DIAGNOSTICS Inc

See all devices from DIAMOND DIAGNOSTICS Inc →

Properties

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