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FlowPRA™ Class Il Positive Control FL2-PC

by One Lambda, Inc.

Part of a family of 8 devices: see the family page

Ref FL2-PC

FlowPRA Class Il Positive Control FL2-PC is a HLA class I & II antibody screening IVD (EU IVDR Class C) made by One Lambda, Inc., registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI 081211701FLP8D) and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00812117011516), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081211701FLP8D Basic UDI-DI 00812117011516UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812117011516 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081211701FLP8D registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI 00812117011516 listed 31 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00812117011516
  2. Registered EUDAMED 081211701FLP8D

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  • Withdrawn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
FlowPRA™ Class II Positive Control EUDAMED
FlowPRA™ Class Il Positive Control GUDID
Generic name
HLA class I & II antibody screening IVD, kit, multiplex
Model / Ref / Catalog
FL2-PC
Primary DI / UDI-DI
00812117011516
Basic UDI-DI
081211701FLP8D
EMDN code
W01030402 Hla antibody screening
GMDN term
HLA class I & II antibody screening IVD, kit, multiplex
Device class
Class C
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

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)