Cancer-Related Germline Gene Mutation Detection System
PJG · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
PJG
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
PA
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
The germline gene mutation test system is an in vitro diagnostic nucleic acid amplification and detection system for the identification of genetic mutations in DNA extracted from human clinical specimens.