MGU — Fluorescence Polarization Immunoassay For Cyclosporine Class II
FDA product code MGU covers "Fluorescence Polarization Immunoassay For Cyclosporine", a Class II medical device regulated under 21 CFR 862.1235. Submissions are reviewed by the Clinical Chemistry panel.
Classification Details
- Product Code
- MGU
- Device Class
- Class II
- Regulation Number
- 862.1235
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Chemistry
- Implant
- No