QTP — Reagents, Monkeypox Virus Nucleic Acid. Class N
FDA product code QTP covers "Reagents, Monkeypox Virus Nucleic Acid.", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QTP
- 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 monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens