SFC
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Neurologic Disease Risk Assessment Molecular Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5850
- Medical specialty
- Immunology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| APO-Easy Genotyping kit (DEN240032) | Firalis SA | 2025-06-12 |
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Every clearance here is in the API, with alerts when new ones post.