Skip to content

Anti-Human Kappa Light Chain

by DB Biotech, a.s. Slovakia EUDAMED

Ref DB 038-RTU-15, DB 037-0.2, DB 037-0.5, DB 037-0.1, DB 038-0.1, DB 038-1, DB 037-RTU-15, DB 038-0.5Model DB 038, DB 037 EMDN W01030705

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number85850389DB038L5 Basic UDI-DIDate24 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
DB 038, DB 038-RTU-15, DB 037, DB 037-0.2, DB 037-0.5, DB 037-0.1, DB 038-0.1, DB 038-1, DB 037-RTU-15, DB 038-0.5
Primary DI / UDI-DI
08585038900413, 08585038900321, 08585038900338, 08585038900314, 08585038900376, 08585038900406, 08585038900352, 08585038900390
Basic UDI-DI
85850389DB038L5, 85850389DB037L3
EMDN Code
W01030705 Fixing reagents (histology/cytology)
Device Class
Class C
Market of Registration
Slovakia

Manufacturer details

EUDAMED SRN
SK-MF-000051838

Other devices from DB Biotech, a.s.

See all devices from DB Biotech, a.s. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (8)

  • EUDAMED c84d2b8d-1a3f-4a8e-8e91-77c34f3b4891 61 fields · synced 22 Oct 2026
  • EUDAMED 08585038900321|85850389DB037L3 61 fields · synced 11 May 2026
  • EUDAMED 08585038900338|85850389DB037L3 61 fields · synced 16 May 2026
  • EUDAMED 08585038900314|85850389DB037L3 61 fields · synced 17 May 2026
  • EUDAMED 08585038900376|85850389DB038L5 61 fields · synced 18 May 2026
  • EUDAMED 08585038900406|85850389DB038L5 61 fields · synced 18 May 2026
  • EUDAMED 08585038900352|85850389DB037L3 61 fields · synced 18 May 2026
  • EUDAMED 08585038900390|85850389DB038L5 61 fields · synced 18 May 2026