UROVYSION BLADDER CANCER KIT
FDA premarket approval P030052 · decided 2005-01-24
Approval details
- PMA number
- P030052
- Trade name
- UROVYSION BLADDER CANCER KIT
- Applicant
- Abbott Molecular
- Date received
- 2003-12-10
- Decision date
- 2005-01-24
- Days to decision
- 411 days
- Decision code
- APPR
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- APPROVAL FOR THE UROVYSION BLADDER CANCER KIT. THE DEVICE IS INDICATED FOR: THE UROVYSION BLADDER CANCER KIT (UROVYSION KIT) IS DESIGNED TO DETECT ANEUPLOIDY FOR CHROMOSOMES 3, 7, 17 AND LOSS OF THE 9P21 LOCUS VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN URINE SPECIMENS FROM PERSONS WITH HEMATURIA SUSPECTED OF HAVING BLADDER CANCER. RESULTS FROM THE UROVYSION KIT ARE INTENDED FOR USE, IN CONJUNCTION WITH AND NOT IN LIEU OF CURRENT STANDARD DIAGNOSTIC PROCEDURES, AS AN AID FOR INITIAL DIAGNOS
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