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IGH Gene Clonality Assay

by Invivoscribe, Inc. 2 variants

Ref 9-101-0081

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00850052003159 Basic UDI-DI 00850052003159UDI-DIDate6 Apr 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  • Withdrawn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

Device Name
IGH Gene Clonality Assay MegaKit for ABI Fluorescence Detection
Model / Reference
9-101-0081
Primary DI / UDI-DI
00850052003159
Basic UDI-DI
B-00850052003159
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000011736
Authorised representative
IN VIVOSCRIBE TECHNOLOGIES FR-AR-000003774

Other devices from Invivoscribe, Inc.

See all devices from Invivoscribe, Inc. →

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