Skip to content

QXDx AutoDG Supermix Pack

by Bio-Rad Laboratories, Inc.

Ref 12003031Model QXDx Universal Kit

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number361052A005098E Basic UDI-DI 03610520144701UDI-DIDate6 Nov 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
QXDx Universal Kit
Model / Reference
QXDx Universal Kit, 12003031
Primary DI / UDI-DI
03610520144701
Basic UDI-DI
361052A005098E
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class A
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000020713
Authorised representative
Bio-Rad FR-AR-000006264

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

  • Animal Tissues
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No