1 device · 1 company · 2023
Product code PQP: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
1 device under product code PQP, 2023, 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 Oncology Panel, Somatic Or Germline Variant Detection System. A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens. MAUDE held 14 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 |
|---|---|---|---|---|
| xT CDxP210011 · PMA | Tempus Labs, Inc. | Pathology | database entry |
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