FDA product code NSD: Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
NSD is the FDA product code for test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence. It is a Class III device, reviewed by the Pathology panel. Devices under NSD reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
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.
Classification
| Field | Value |
|---|---|
| Device name | Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence |
| Device class | Class III |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for NSD devices
openFDA lists no recalls for product code NSD.
Frequently asked questions
What is FDA product code NSD?
NSD is the FDA product code for test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence. It is a Class III device, reviewed by the Pathology panel.
What device class is NSD?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NSD
- Run a recall and safety report across every NSD manufacturer
- Watch product code NSD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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