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NxTAG® Respiratory Pathogen Panel v2

by Luminex Molecular Diagnostics, Inc.

Ref I055C0467

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08408471NxTAGRPPRP Basic UDI-DI 00840487101889UDI-DIDate29 Sep 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
I055C0467
Primary DI / UDI-DI
00840487101889
Basic UDI-DI
08408471NxTAGRPPRP
Direct Marketing DI
00840487101889
EMDN Code
W0105070503 Respiratory tract infections - multiplex na reagents
Device Class
Class B
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CA-MF-000042007
Authorised representative
DiaSorin Italia S.p.A. IT-AR-000029423

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Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (8)

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