Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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US Regulatory Classifications
Device Characteristics
No
No
No
Not Eligible
Definition
In vitro diagnostic test 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 suspected of having bladder cancer. It is an adjunctive test for initial diagnosis of transitional cell carcinoma in symptomatic patients and subsequently monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
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