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FlowPRA™ Reagent Pack

by One Lambda, Inc.

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

Ref FL-RP

FlowPRA Reagent Pack (FL-RP) is an in vitro diagnostic device (EU IVDR Class C; EMDN category hla antibody screening) made by One Lambda, Inc., registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI 081211701FLP8D), active as of 7 Nov 2026.

Active European Union

CE IVDR

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081211701FLP8D Basic UDI-DI 00812117011554UDI-DIDate21 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
FlowPRA™ Screening Test
Model / reference
FL-RP
Primary DI / UDI-DI
00812117011554
Basic UDI-DI
081211701FLP8D
EMDN code
W01030402 Hla antibody screening
Device class
Class C
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

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

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

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (8, all answered No)