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PakPlus®

by Immucor GTI Diagnostics, Inc

Ref PAKPLUS

PakPlus is a HLA class I antibody screening IVD (EU IVDR Class C; FDA Class II; FDA product code MYP, Test,Platelet Antibody) made by Immucor GTI Diagnostics, Inc, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 08500795051B9N), listed under FDA premarket submission BK140163 and listed in FDA GUDID since 8 Jul 2016 (UDI-DI 10850079505183), 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) BK140163

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 Number08500795051B9N Basic UDI-DI 10850079505183UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10850079505183 UDI-DI Date8 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberBK140163 Date—StatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08500795051B9N registered 5 Nov 2026 Active
  • FDA premarket submission BK140163 Active
  • FDA GUDID UDI-DI 10850079505183 listed 8 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10850079505183
  2. Registered EUDAMED 08500795051B9N

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  • Withdrawn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

Generic name
HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
PAKPLUS
Primary DI / UDI-DI
10850079505183 EUDAMED
10888234500254 GUDID
Basic UDI-DI
08500795051B9N
Direct marketing DI
10850079505183
FDA product code
MYP
EMDN code
W01030402 Hla antibody screening
GMDN term
HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA)
Device class
Class C EUDAMED
Class II 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
10850079505183
GUDID
10888234500254
Device classEUDAMED
Class C
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 10850079505183; FDA GUDID lists 10888234500254), so their flags are not compared. Device class is stated on each registry's own scale: Class C in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA)

Similar devices in this category

Other devices filed under TISSUE TYPING REAGENTS.

Other devices from Immucor GTI Diagnostics, Inc

See all devices from Immucor GTI Diagnostics, Inc →

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)