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Oncomine™ Dx Target Test (DNA and RNA Panel)

by Life Technologies Corporation

Ref A65534 （A65538)

Active European Union

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0190302A49756TV Basic UDI-DI 10190302019620UDI-DIDate24 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Oncomine™ Dx Target Test
Model / Reference
A65534 （A65538)
Primary DI / UDI-DI
10190302019620
Basic UDI-DI
0190302A49756TV
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class C
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000023929
Authorised representative
Life Technologies Europe B.V. NL-AR-000021890

Other devices from Life Technologies Limited

See all devices from Life Technologies Limited →

Properties

  • Reagent
  • Professional Testing
  • Companion Diagnostics
  • New Device

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No