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LABScreen™ Single Antigen HLA Class II ExPlex - Group 2

by One Lambda, Inc.

Ref LS2AEX02

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081211701LSLJ Basic UDI-DI 00814695025961UDI-DIDate4 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  • Withdrawn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

Device Name
LABScreen
Model / Reference
LS2AEX02
Primary DI / UDI-DI
00814695025961
Basic UDI-DI
081211701LSLJ
EMDN Code
W01030402 Hla antibody screening
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000024901
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • New Device

Other properties (6)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No