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LABScreen™ PRA Class I LS1PRA

by One Lambda, Inc.

Part of a family of 13 devices: see the family page

Ref LS1PRA

LABScreen PRA Class I LS1PRA is a HLA class I & II antibody screening IVD (EU IVDR Class C; FDA unclassified; FDA product code MZI, Test,Qualitative,For Hla,Non-Diagnostic) made by One Lambda, Inc., registered in EUDAMED on 4 Jun 2026 (Basic UDI-DI 081211701LSLJ) and listed in FDA GUDID since 11 Aug 2016 (UDI-DI 00812117011561), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081211701LSLJ Basic UDI-DI 00812117011561UDI-DIDate4 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812117011561 UDI-DI Date11 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081211701LSLJ registered 4 Jun 2026 Active
  • FDA GUDID UDI-DI 00812117011561 listed 11 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00812117011561
  2. Registered EUDAMED 081211701LSLJ

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  • Withdrawn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
LABScreen™ PRA Class I
Generic name
HLA class I & II antibody screening IVD, kit, multiplex
Model / Ref / Catalog
LS1PRA
Primary DI / UDI-DI
00812117011561
Basic UDI-DI
081211701LSLJ
FDA product code
MZI
EMDN code
W01030402 Hla antibody screening
GMDN term
HLA class I & II antibody screening IVD, kit, multiplex
Device class
Class C EUDAMED
U GUDID
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
U

Device class is stated on each registry's own scale: Class C in the EU (EUDAMED), U in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: HLA class I & II antibody screening IVD, kit, multiplex

Similar devices in this category

Other devices filed under TISSUE TYPING REAGENTS.

Other devices from One Lambda, Inc.

See all devices from One Lambda, Inc. →

Properties

  • Single use
  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (15, all answered No)