NVA — Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma Class II

FDA Device Classification

FDA product code NVA covers "Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma", a Class II medical device regulated under 21 CFR 866.6010. Submissions are reviewed by the Immunology panel.

Classification Details

Product Code
NVA
Device Class
Class II
Regulation Number
866.6010
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Definition

MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES.