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Serotonin ELISA

by LDN Labor Diagnostika Nord GmbH & Co. KG

Ref BA E-8900I

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426020226BAE8900HP Basic UDI-DI 04260202266994UDI-DIDate26 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
BA E-8900I
Primary DI / UDI-DI
04260202266994
Basic UDI-DI
426020226BAE8900HP
Direct Marketing DI
04260202266994
EMDN Code
W01029099 Immunochemistry reagents - other
Device Class
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000023995

From the manufacturer

Manufacturer's product page: SEROTONIN ELISA FAST TRACK

Other devices from LDN Labor Diagnostika Nord GmbH & Co. KG

Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No