QJR — Reagents, 2019-Novel Coronavirus Nucleic Acid Class N
FDA product code QJR covers "Reagents, 2019-Novel Coronavirus Nucleic Acid", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QJR
- 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 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens.