OYA

P2psa

Product code: OYA
Device name: P2psa
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification 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)

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OYA

Classification and pathway per current FDA publications. Data from openFDA (CC0).