Test, Fluorescence In Situ Hybridization (fish), For Bladder Cancer Detection And Monitoring For Recurrence
Device Code: 5039
Product Code(s):
NSD 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 D
Device Classification Information
| Device Type ID | 5039 |
| Device Name | Test, Fluorescence In Situ Hybridization (fish), For Bladder Cancer Detection And Monitoring For Recurrence |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NSD |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 5039 |
| Device | Test, Fluorescence In Situ Hybridization (fish), For Bladder Cancer Detection And Monitoring For Recurrence |
| Product Code | NSD |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems |
|---|
Defective Component | 1 |
| Total Device Problems | 1 |
TPLC Last Update: 2019-04-02 20:59:12