QTU — Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests Class N
FDA product code QTU covers "Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QTU
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Unknown
- Implant
- No
Definition
Antigen-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus or monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens-EXPORT ONLY