FDA product code MGM: C. Trachomatis (Chlamydia Group)
MGM is the FDA product code for c. trachomatis (chlamydia group). It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel. Devices under MGM reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 3 recalls for MGM devices.
Classification
| Field | Value |
|---|---|
| Device name | C. Trachomatis (Chlamydia Group) |
| Device class | Class I |
| Regulation | 21 CFR 866.3120 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for MGM devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-08-27.
Frequently asked questions
What is FDA product code MGM?
MGM is the FDA product code for c. trachomatis (chlamydia group). It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel.
What device class is MGM?
Class I, regulation 21 CFR 866.3120. Typical premarket route: 510(k).
Have MGM devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2008-08-27.
Next steps
- Run an FDA pathway report with predicate devices for product code MGM
- Run a recall and safety report across every MGM manufacturer
- Watch product code MGM 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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