POG — Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid Class N
FDA product code POG covers "Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- POG
- 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 presumptive detection and identification of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in human clinical specimens