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Reagent 1077/A5

by Chromsystems Instruments & Chemicals GmbH

Part of a family of 27 devices: see the family page

Ref 1077/A5

Reagent 1077/A5 is a HVA/VMA/5HIAA IVD (EU IVDR Class C; FDA Class I; FDA product code CDF, Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin) made by Chromsystems Instruments & Chemicals GmbH, registered in EUDAMED on 27 Aug 2026 (Basic UDI-DI 42503171000C43) and listed in FDA GUDID since 31 Aug 2020 (UDI-DI 04250317500564), 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 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/IVDR EUDAMED Number42503171000C43 Basic UDI-DI 04250317500564UDI-DIDate27 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250317500564 UDI-DI Date31 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42503171000C43 registered 27 Aug 2026 Active
  • FDA GUDID UDI-DI 04250317500564 listed 31 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250317500564
  2. Registered EUDAMED 42503171000C43

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  • Withdrawn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
Elution Buffer EUDAMED
Reagent GUDID
Generic name
HVA/VMA/5HIAA IVD, reagent
Model / Ref / Catalog
1077/A5
Primary DI / UDI-DI
04250317500564
Basic UDI-DI
42503171000C43
FDA product code
CDF
EMDN code
W01019099 Clinical chemistry reagents - other
GMDN term
HVA/VMA/5HIAA IVD, reagent
Device class
Class C EUDAMED
Class I GUDID
Regulation number
862.1795
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: HVA/VMA/5HIAA IVD, reagent

Similar devices

Also classified as HVA/VMA/5HIAA IVD, reagent.

Similar devices in this category

Other devices filed under CLINICAL CHEMISTRY REAGENTS - OTHER.

Other devices from Chromsystems Instruments & Chemicals GmbH

See all devices from Chromsystems Instruments & Chemicals GmbH →

Properties

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