1 device · 1 company · 2025
Product code PZM: Next Generation Sequencing Based Tumor Profiling Test
1 device under product code PZM, 2025, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Next Generation Sequencing Based Tumor Profiling Test. 21 CFR 866.6080, Class II. A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens obtained from patients diagnosed with malignant solid neoplasms using targeted next-generation sequencing. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| GENESEEQPRIME NGS Tumor Profiling AssayK250003 · 510(k) | Geneseeq Technology Inc. | Pathology | database entry |
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