FDA product code LGB: Gonococcal Antibody Tests
LGB is the FDA product code for gonococcal antibody tests. It is a Class III device, regulated under 21 CFR 866.3290 and reviewed by the Microbiology panel. Devices under LGB 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 LGB devices.
Classification
| Field | Value |
|---|---|
| Device name | Gonococcal Antibody Tests |
| Device class | Class III |
| Regulation | 21 CFR 866.3290 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | PMA |
Recalls for LGB devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-05-26.
Frequently asked questions
What is FDA product code LGB?
LGB is the FDA product code for gonococcal antibody tests. It is a Class III device, regulated under 21 CFR 866.3290 and reviewed by the Microbiology panel.
What device class is LGB?
Class III, regulation 21 CFR 866.3290. Typical premarket route: PMA.
Have LGB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-05-26.
Next steps
- Run an FDA pathway report with predicate devices for product code LGB
- Run a recall and safety report across every LGB manufacturer
- Watch product code LGB 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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