FDA product code PJG: Cancer-Related Germline Gene Mutation Detection System
PJG is the FDA product code for cancer-related germline gene mutation detection system. It is a Class III device, reviewed by the Pathology panel. Devices under PJG reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cancer-Related Germline Gene Mutation Detection System |
| Device class | Class III |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for PJG devices
openFDA lists no recalls for product code PJG.
Frequently asked questions
What is FDA product code PJG?
PJG is the FDA product code for cancer-related germline gene mutation detection system. It is a Class III device, reviewed by the Pathology panel.
What device class is PJG?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PJG
- Run a recall and safety report across every PJG manufacturer
- Watch product code PJG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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