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deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16 rxn)

by IST Innuscreen GmbH

Ref 31-DP-5010016, 31-DP-4010016

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4262375220038M Basic UDI-DI Date11 Apr 2024RegisteredStatusActive

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  • Withdrawn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

Trade Name
deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16 rxn)
deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16 rxn) Plates
Device Name
deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16rxn) Stripes
Model / Reference
31-DP-5010016, 31-DP-4010016
Primary DI / UDI-DI
04262375223019, 04262375223026
Basic UDI-DI
4262375220038M
Direct Marketing DI
04262375223019
04262375223026
EMDN Code
W01019001 Buffers (unassignable), supplem. reagents, etc (cc)
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000024606

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

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