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AlloSeq Tx 9

by CareDx Pty Ltd EUDAMED

Active European Union

Ref ASTX9.1(96)-A-IVDModel AlloSeq Tx 9(96) Set A

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-19358706000052 Basic UDI-DIDate4 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
AlloSeq Tx 9
Model / Reference
AlloSeq Tx 9(96) Set A, ASTX9.1(96)-A-IVD
Primary DI / UDI-DI
19358706000052
Basic UDI-DI
B-19358706000052
EMDN Code
W01030403 Hla antigen typing
Device Class
Class IVD Annex II List B
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
AU-MF-000046711
Authorised representative
QbD RepS BV BE-AR-000000040

Related devices

Category: HLA class I & II antigen tissue typing IVD, kit, multiplex

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Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No