FDA Product Code SFC: Neurologic Disease Risk Assessment Molecular Test
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.
Leading manufacturers include Firalis SA.
FDA 510(k) Cleared Neurologic Disease Risk Assessment Molecular Test Devices (Product Code SFC)
About Product Code SFC - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SFC since 2025, with 0 receiving FDA clearance (average review time: 356 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SFC devices are reviewed by the Immunology panel. Browse all Immunology devices →