NWY — Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies Class N

FDA Device Classification

FDA product code NWY covers "Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies", a Class N medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code
NWY
Device Class
Class N
Regulation Number
Submission Type
Review Panel
MI
Medical Specialty
Unknown
Implant
No

Definition

Intended for the detection of IgM and IgG antibodies to dengue virus in human serum, plasma or whole blood.