Skip to content

Vysis

by Abbott Molecular Inc. 9 variants

Ref 08N85-085

Vysis (08N85-085) is a Class A device made by Abbott Molecular, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 0884999VyN0885T9), active as of 7 Nov 2026.

Active European Union

CE IVDR

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/IVDR Number0884999VyN0885T9 Basic UDI-DI 00884999046849UDI-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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device name
Vysis Intellifish Universal Ffpe Tissue Pretreatment Protease Kits and Wash Reagent Kit
Model / reference
08N85-085
Primary DI / UDI-DI
00884999046849
Basic UDI-DI
0884999VyN0885T9
EMDN code
W01030799 Histology / cytology reagents - other
Device class
Class A
EU registration type
Standard device
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 HISTOLOGY / CYTOLOGY REAGENTS - OTHER.

Other devices from Abbott Molecular

See all devices from Abbott Molecular →

Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (9, all answered No)