FDA product code SFC: Neurologic Disease Risk Assessment Molecular Test
SFC is the FDA product code for neurologic disease risk assessment molecular test. It is a Class II device, regulated under 21 CFR 866.5850 and reviewed by the Immunology panel. Devices under SFC reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A neurologic disease predisposition risk assessment system is a prescription in vitro diagnostic device intended to detect or measure DNA, RNA, or protein variants in human specimens. The measurements aid in the evaluation of the risk of developing a neurologic disease in patients presenting with symptoms and/or with disease-associated risk factors to aid in patient management, in conjunction with other laboratory and clinical information.
Classification
| Field | Value |
|---|---|
| Device name | Neurologic Disease Risk Assessment Molecular Test |
| Device class | Class II |
| Regulation | 21 CFR 866.5850 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
Recalls for SFC devices
openFDA lists no recalls for product code SFC.
Frequently asked questions
What is FDA product code SFC?
SFC is the FDA product code for neurologic disease risk assessment molecular test. It is a Class II device, regulated under 21 CFR 866.5850 and reviewed by the Immunology panel.
What device class is SFC?
Class II, regulation 21 CFR 866.5850. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SFC
- Run a recall and safety report across every SFC manufacturer
- Watch product code SFC 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.