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Vysis 07J22-012

by Abbott Molecular

Ref 07J22-012

Vysis 07J22-012 is a device classified as IVD General (EU), Class I (US) made by Abbott Molecular, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-00884999027084), cleared under FDA 510(k) K962873 on 13 Jan 1997 and listed in FDA GUDID since 10 Sep 2016 (UDI-DI 00884999027084), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K962873

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00884999027084 Basic UDI-DI 00884999027084UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884999027084 UDI-DI Date10 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK962873 Date13 Jan 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00884999027084 registered 5 Nov 2026 Active
  • FDA 510(k) K962873 decided 13 Jan 1997 Active
  • FDA GUDID UDI-DI 00884999027084 listed 10 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K962873
  2. Listed FDA GUDID 00884999027084
  3. Registered EUDAMED B-00884999027084

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Vysis
Generic name
Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe
Model / Ref / Catalog
07J22-012
Primary DI / UDI-DI
00884999027084
Basic UDI-DI
B-00884999027084
510(k) Number
FDA product code
KIR, OVQ
EMDN code
W01060299 Tests for acquired genetic or chromosomal alterations - other
GMDN term
Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
864.2280, 866.6040
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class I

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe

Cleared under the same submission (K962873)

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

  • Single use
  • Contains human tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)