Vysis
Country not established
- Devices
- 9
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Urovysion Bladder Cancer Recurrence Kit Ref K013785
510(k) 510(k)- 510(k) 510(k)
- 510(k) 510(k)
Vysis Autovysion System Ref DEN040010
De Novo 510(k)Cep 8 Spectrumorange Dna Probe Kit Ref K953591
510(k) 510(k)- 510(k) 510(k)
Vysis Urovysion Bladder Cancer Recurrence Kit Ref K011031
510(k) 510(k)Aneuvysion Ref K972200
510(k) 510(k)Aneuvysion Muliticolor Dna Probe Kit Ref K010288
510(k) 510(k)
FDA recalls
2004
- 19 Feb 2004 Z-0640-04 Unclassified (pre-2012) Terminated Some of the control slides did not have adequate cells deposited upon their surface.
Full distribution text
- 19 Feb 2004 Z-0640-04 Unclassified (pre-2012) Terminated Some of the control slides did not have adequate cells deposited upon their surface.
Frequently asked questions
How many devices does Vysis have in the registry?
The registry currently lists 9 devices for Vysis. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vysis's devices?
Among its 9 most recently registered devices, Vysis has devices listed in FDA 510(k) (9 devices).
What risk classes do Vysis's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Vysis's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Vysis?
FDA recall records list 1 recall initiated by Vysis, the most recent initiated on 2004-02-19. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Vysis in the registry?
The most recently registered devices listed for Vysis include UROVYSION BLADDER CANCER RECURRENCE KIT, CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT, CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE and VYSIS AUTOVYSION SYSTEM.