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Diluent solution

by Diamond Diagnostics Inc 8 variants

Ref BM-820637D

Diluent solution (BM-820637D) is a Class A device made by DIAMOND DIAGNOSTICS Inc, registered in EUDAMED on 10 May 2024 (Basic UDI-DI 081140301BM820637DFG) and listed in FDA GUDID since 12 Jun 2023 (UDI-DI 00811403012701), 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 Number081140301BM820637DFG Basic UDI-DI 00811403012701UDI-DIDate10 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00811403012701 UDI-DI Date12 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081140301BM820637DFG registered 10 May 2024 Active
  • FDA GUDID UDI-DI 00811403012701 listed 12 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00811403012701
  2. Registered EUDAMED 081140301BM820637DFG

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  • Withdrawn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
ISE Diluent GUDID
Generic name
Buffered sample diluent IVD
Device name
ISE Diluent HT902
Model / reference
BM-820637D
Primary DI / UDI-DI
00811403012701
Basic UDI-DI
081140301BM820637DFG
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)