FDA product code PQP

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

Unknown·Class 3·21 CFR
US regulatory classifications
US Product Code (FDA)
PQP
View Product Code Classification →
US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR
View CFR Regulation →
Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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.

Search keywords
About this record

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System 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.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.