OYA — P2psa Class III
FDA product code OYA covers "P2psa", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OYA
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Unknown
- Implant
- No
Definition
Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)