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Reagent 3035

by Chromsystems Instruments & Chemicals GmbH

Ref 3035

Reagent 3035 is a multiple biogenic amine neurotransmitter IVD (EU IVDD general IVD; FDA Class I; FDA product code CDA, Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin) made by Chromsystems Instruments & Chemicals GmbH, registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI B-04250317505415) and listed in FDA GUDID since 27 Aug 2020 (UDI-DI 04250317505415), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

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/IVDD EUDAMED NumberB-04250317505415 Basic UDI-DI 04250317505415UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250317505415 UDI-DI Date27 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250317505415 registered 21 Sep 2026 Active
  • FDA GUDID UDI-DI 04250317505415 listed 27 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250317505415
  2. Registered EUDAMED B-04250317505415

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Precipitation Reagent EUDAMED
Reagent GUDID
Generic name
Multiple biogenic amine neurotransmitter IVD, reagent
Model / Ref / Catalog
3035
Primary DI / UDI-DI
04250317505415
Basic UDI-DI
B-04250317505415
FDA product code
CDA
EMDN code
W01019099 Clinical chemistry reagents - other
GMDN term
Multiple biogenic amine neurotransmitter IVD, reagent
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1390
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class I

Device class is stated on each registry's own scale: Class IVD General 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: Multiple biogenic amine neurotransmitter IVD, reagent

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Other devices filed under CLINICAL CHEMISTRY REAGENTS - OTHER.

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Properties

  • Reagent
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)