FDA product code MGX: Test System, For Drugs Of Abuse
MGX is the FDA product code for test system, for drugs of abuse. It is a Class III device, reviewed by the Clinical Toxicology panel. Devices under MGX reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for MGX devices.
Classification
| Field | Value |
|---|---|
| Device name | Test System, For Drugs Of Abuse |
| Device class | Class III |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MGX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-11-21.
Frequently asked questions
What is FDA product code MGX?
MGX is the FDA product code for test system, for drugs of abuse. It is a Class III device, reviewed by the Clinical Toxicology panel.
What device class is MGX?
Class III. Typical premarket route: PMA.
Have MGX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-11-21.
Next steps
- Run an FDA pathway report with predicate devices for product code MGX
- Run a recall and safety report across every MGX manufacturer
- Watch product code MGX 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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