P2psa
FDA product code OYA · Class III (high risk) · Immunology
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)
0510(k) clearances
1PMA approvals
1recalls
PMA approvals
- P090026 Access Hybritech P2PSA on the Access Immunoassay Systems · Beckman Coulter, Inc. · 06/14/2012
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2043-2023 Class II | Access Hybritech p2PSA reagent, REF B03704 and REF A49752.Reagent lot numbers include an insufficient concentration of blocking reagent. | Beckman Coulter, Inc. | 05/17/2023Open, Classified |