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Open lyophilized One-Step qPCR Kit IVD

by AD Nucleis EUDAMED

Active European Union

Ref KIT-A_OPCR_100LModel Open lyophilized One-Step qPCR Kit IVD

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number376042770OPENQPGW Basic UDI-DIDate14 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Open lyophilized One-Step qPCR Kit IVD, KIT-A_OPCR_100L
Primary DI / UDI-DI
37604277001018
Basic UDI-DI
376042770OPENQPGW
Direct Marketing DI
37604277001018
EMDN Code
W0105900102 Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000002215

Other devices from AD Nucleis

See all devices from AD Nucleis →

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing
  • New Device

Other properties (7)

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