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SeCore™ GSSP Kit A11256

by One Lambda, Inc.

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

Ref A11256

SeCore GSSP Kit A11256 is a HLA class I & II antigen tissue typing 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 20 May 2026 (Basic UDI-DI 081469502SECGZ) and listed in FDA GUDID since 27 Apr 2018 (UDI-DI 00814695022519), 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 Number081469502SECGZ Basic UDI-DI 00814695022519UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00814695022519 UDI-DI Date27 Apr 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081469502SECGZ registered 20 May 2026 Active
  • FDA GUDID UDI-DI 00814695022519 listed 27 Apr 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00814695022519
  2. Registered EUDAMED 081469502SECGZ

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  • Withdrawn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
SeCore GSSP EUDAMED
SeCore™ GSSP Kit GUDID
Generic name
HLA class I & II antigen tissue typing IVD, kit, multiplex
Device name
SeCore™ HLA Sequencing System
Model / Ref / Catalog
A11256
Primary DI / UDI-DI
00814695022519
Basic UDI-DI
081469502SECGZ
FDA product code
MZI
EMDN code
W01030403 Hla antigen typing
GMDN term
HLA class I & II antigen tissue typing 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 antigen tissue typing IVD, kit, multiplex

Similar devices

Also classified as HLA class I & II antigen tissue typing IVD, kit, multiplex.

Similar devices in this category

Other devices filed under HLA ANTIGEN TYPING.

Other devices from One Lambda, Inc.

See all devices from One Lambda, Inc. →

Properties

  • Single use
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)