FDA product code LFS: Radioreceptor Assay, Human Chorionic Gonadotropin
LFS is the FDA product code for radioreceptor assay, human chorionic gonadotropin. It is a Class II device, regulated under 21 CFR 862.1155 and reviewed by the Clinical Chemistry panel. Devices under LFS reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radioreceptor Assay, Human Chorionic Gonadotropin |
| Device class | Class II |
| Regulation | 21 CFR 862.1155 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for LFS devices
openFDA lists no recalls for product code LFS.
Frequently asked questions
What is FDA product code LFS?
LFS is the FDA product code for radioreceptor assay, human chorionic gonadotropin. It is a Class II device, regulated under 21 CFR 862.1155 and reviewed by the Clinical Chemistry panel.
What device class is LFS?
Class II, regulation 21 CFR 862.1155. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code LFS
- Run a recall and safety report across every LFS manufacturer
- Watch product code LFS 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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