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Vysis

by Abbott Molecular Inc. 6 variants

Ref 01N35-020

Vysis (01N35-020) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category tests for acquired genetic or chromosomal alterations) made by Abbott Molecular, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-00884999000773), active as of 7 Nov 2026.

Active European Union

CE IVDD

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00884999000773 Basic UDI-DI 00884999000773UDI-DIDate5 Nov 2026RegisteredStatusActive

Official records

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  • Withdrawn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
Vysis EGFR/CEP 7 FISH Probe Kit
Model / reference
01N35-020
Primary DI / UDI-DI
00884999000773
Basic UDI-DI
B-00884999000773
EMDN code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000017776
Authorised representative
Abbott GmbH DE-AR-000009457

Similar devices in this category

Other devices filed under TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER.

Other devices from Abbott Molecular

See all devices from Abbott Molecular →

Properties

  • Contains human tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
Other properties (8, all answered No)