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Reagent 80605

by Chromsystems Instruments & Chemicals GmbH

Part of a family of 20 devices: see the family page

Ref 80605

Reagent 80605 is a multiple biogenic amine neurotransmitter IVD (EU IVDR Class C; FDA Class I; FDA product code CHQ, Chromatographic/Fluorometric Method, Catecholamines) made by Chromsystems Instruments & Chemicals GmbH, registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI 4250317806006A) and listed in FDA GUDID since 27 Aug 2020 (UDI-DI 04250317537249), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number4250317806006A Basic UDI-DI 04250317537249UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250317537249 UDI-DI Date27 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4250317806006A registered 17 Sep 2026 Active
  • FDA GUDID UDI-DI 04250317537249 listed 27 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250317537249
  2. Registered EUDAMED 4250317806006A

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  • Withdrawn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
Neutralisation Buffer EUDAMED
Reagent GUDID
Generic name
Multiple biogenic amine neurotransmitter IVD, reagent
Device name
MassChrom® Biogenic Amines / Metabolites in Urine Sample Prep Set Catecholamines, free Metanephrines, Serotonin
Model / Ref / Catalog
80605
Primary DI / UDI-DI
04250317537249
Basic UDI-DI
4250317806006A
FDA product code
CHQ
EMDN code
W01019099 Clinical chemistry reagents - other
GMDN term
Multiple biogenic amine neurotransmitter IVD, reagent
Device class
Class C EUDAMED
Class I GUDID
Regulation number
862.1165
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class C
GUDID
Class I

Device class is stated on each registry's own scale: Class C 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

Similar devices in this category

Other devices filed under CLINICAL CHEMISTRY REAGENTS - OTHER.

Other devices from Chromsystems Instruments & Chemicals GmbH

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Properties

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