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

Cancer-Related Germline Gene Mutation Detection System

Unknown
FDA source (opens on fda.gov)

PJG is the FDA product code for Cancer-Related Germline Gene Mutation Detection System, a class III device type. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PJG
Device name
Cancer-Related Germline Gene Mutation Detection System
FDA 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.
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
0

Companies listing this code with FDA

Companies whose registered establishments list this code