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LIFECODES LifeScreen XP 628220

by Immucor GTI Diagnostics, Inc

Ref 628220

LIFECODES LifeScreen XP 628220 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 Immucor GTI Diagnostics, Inc, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 08500795054A9V), listed under FDA premarket submission BK220763 and listed in FDA GUDID since 11 Jul 2023 (UDI-DI 10850079505145), active as of 8 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) BK220763

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number08500795054A9V Basic UDI-DI 10850079505145UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10850079505145 UDI-DI Date11 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberBK220763 Date—StatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08500795054A9V registered 5 Nov 2026 Active
  • FDA premarket submission BK220763 Active
  • FDA GUDID UDI-DI 10850079505145 listed 11 Jul 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10850079505145
  2. Registered EUDAMED 08500795054A9V

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
LIFECODES LifeScreen XP
Generic name
HLA class I & II antigen tissue typing IVD, kit, multiplex
Model / Ref / Catalog
628220
Primary DI / UDI-DI
10850079505145 EUDAMED
10888234500841 GUDID
Basic UDI-DI
08500795054A9V
Direct marketing DI
10850079505145
FDA product code
MZI
EMDN code
W01030402 Hla antibody screening
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 · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10850079505145
GUDID
10888234500841
Device classEUDAMED
Class C
GUDID
U

The registries describe this device under different primary UDI-DIs (EUDAMED lists 10850079505145; FDA GUDID lists 10888234500841), so their flags are not compared. 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 in this category

Other devices filed under TISSUE TYPING REAGENTS.

Other devices from Immucor GTI Diagnostics, Inc

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Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)