Product code OYA
- Device name
- P2psa
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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)
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P090026S032 | Access Hybritech p2PSA | Beckman Coulter, Inc. | 2025-06-16 |
| P090026S031 | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2022-12-16 |
| P090026S030 | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2020-12-16 |
| P090026S029 | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2020-10-16 |
| P090026S028 | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2020-10-07 |
| P090026S027 | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2020-03-17 |
| P090026S026 | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2019-08-09 |
| P090026S025 | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2019-07-31 |
| P090026S023 | Access Hybritech p2PSA Reagent Pack | Beckman Coulter, Inc. | 2019-01-09 |
| P090026S022 | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2018-12-21 |
| P090026S021 | Access Hybritech p2PSA Reagents on the Access Immunoassay System | Beckman Coulter, Inc. | 2017-10-24 |
| P090026S019 | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2017-07-07 |
| P090026S018 | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2017-06-16 |
| P090026S017 | ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2017-02-21 |
| P090026S016 | ACCESS P2PSA CALIBRATOR ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Coulter, Inc. | 2017-02-14 |
| P090026S015 | ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2015-06-23 |
| P090026S014 | ACCESS HYBRITECH P2SA REAGENTS ON THE ACCESS IMMUNCASSAY SYSTEM | Beckman Coulter, Inc. | 2015-03-20 |
| P090026S012 | ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2014-12-23 |
| P090026S013 | ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2014-10-24 |
| P090026S011 | ACCESS HYBRITECH P2PSA ON TH ACCESS IMMNUNOASSAY SYSTEM | Beckman Coulter, Inc. | 2014-07-07 |
| P090026S010 | ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2014-05-01 |
| P090026S009 | ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2013-10-17 |
| P090026S008 | ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2013-10-17 |
| P090026S007 | ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2013-08-20 |
| P090026S006 | ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2013-06-07 |
| P090026S005 | ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM | Beckman Coulter, Inc. | 2013-03-26 |
| P090026S004 | ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2013-02-06 |
| P090026S001 | ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM | Beckman Coulter, Inc. | 2012-11-19 |
| P090026 | ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2012-06-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| H628B037041 | Access Hybritech p2PSA | Beckman Coulter, Inc. | 2014-09-16 |
| H628B037051 | Access Hybritech p2PSA Calibrators | Beckman Coulter, Inc. | 2014-09-16 |