QRF — Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer Class III
FDA product code QRF covers "Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QRF
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Unknown
- Implant
- No
Definition
Test system that combines values from multiple assays with/without other patient information to yield a score value for aid in detection of prostate cancer and/or decision for prostate biopsy.