510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PQPClass III

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

Unknown
FDA source (opens on fda.gov)

PQP is the FDA product code for Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System, a class III device type. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and 18 recalls.

Classification record

Product code
PQP
Device name
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
18

Companies listing this code with FDA

Companies whose registered establishments list this code