POA — Reagents, Zika Virus Nucleic Acid Class N

FDA Device Classification

FDA product code POA covers "Reagents, Zika Virus Nucleic Acid", a Class N medical device. Submissions are reviewed by the Unknown panel.

Classification Details

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

Definition

Nucleic acid-based in vitro diagnostic devices for the detection of Zika virus and diagnosis of Zika virus infection in human clinical specimens.