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Next Generation Sequencing Based Tumor Profiling Test

FDA product code PZM · 7 cleared devices

Class 2 Pathology
Regulation
21 CFR 866.6080
Review panel
PA
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2019-11-09 – 2026-05-12

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.

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