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RevoDx Neisseria Meningitidis qPCR Kit

by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. 2 variants

Ref IP202235-100, IP202507-25

Active European Union

CE IVDD

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/IVDD NumberB-08683079717776 Basic UDI-DI Date4 May 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Trade Name
RevoDx Neisseria Meningitidis qPCR Kit
RevoDx Haemophilus influenzae / Neisseria Meningitidis / Streptococcus pneumoniae qPCR Kit
Model / Reference
IP202235-100, IP202507-25
Primary DI / UDI-DI
08683079717776, 08684387213608
Basic UDI-DI
B-08683079717776, B-08684387213608
EMDN Code
W0105011611, W0105070505
Device Class
Class IVD General
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000047330

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

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