Product code MTF
- Device name
- Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
- 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
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P990056S046 | ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET | Roche Diagnostics Corp. | 2026-04-29 |
| P930027S038 | IMMULITE 2000 PSA | Siemens Healthcare Diagnostics, Inc. | 2026-04-21 |
| P990056S045 | Elecsys total PSA assay | Roche Diagnostics Corp. | 2026-02-27 |
| P910007S068 | ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92) | Abbott Laboratories | 2026-02-23 |
| P910007S067 | ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92) | Abbott Laboratories | 2026-02-12 |
| P240021 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | 2025-12-03 |
| P930027S037 | IMMULITE 2000 PSA | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |
| P930027S036 | IMMULITE 2000 Prostate-Specific Antigen (PSA) | Siemens Healthcare Diagnostics, Inc. | 2025-08-14 |
| P990056S044 | ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET | Roche Diagnostics Corp. | 2025-05-27 |
| P020027S042 | Dimension FPSA Flex reagent cartridge | Siemens Healthcare Diagnostics | 2025-05-22 |
| P910007S066 | ARCHITECT Total PSA / Alinity i Total PSA | Abbott Laboratories | 2025-04-03 |
| P930027S035 | IMMULITE® 2000 Prostate-Specific Antigen (PSA) | Siemens Healthcare Diagnostics, Inc. | 2025-02-21 |
| P930027S034 | IMMULITE 2000 Prostate-Specific Antigen (PSA) | Siemens Healthcare Diagnostics, Inc. | 2025-01-15 |
| P990056S042 | Elecsys total PSA Test System | Roche Diagnostics Corp. | 2024-10-17 |
| P850048S060 | Access Hybritech PSA | Beckman Coulter, Inc. | 2024-09-04 |
| P990056S043 | Elecsys total PSA | Roche Diagnostics Corp. | 2024-08-30 |
| P990056S041 | Elecsys total PSA | Roche Diagnostics Corp. | 2024-02-08 |
| P910007S065 | ARCHITECT Total PSA / Alinity i Total PSA | Abbott Laboratories | 2023-12-14 |
| P910007S064 | Alinity i Total PSA Reagent Kit | Abbott Laboratories | 2023-11-08 |
| P980007S049 | ARCHITECT Free PSA, Alinity i Free PSA | Abbott Laboratories | 2023-10-11 |
| P910007S060 | ARCHITECT Total PSA, Alinity i Total PSA | Abbott Laboratories | 2023-10-11 |
| P990056S040 | Elecsys free PSA | Roche Diagnostics Corp. | 2023-10-05 |
| P910007S063 | Alinity i Total PSA | Abbott Laboratories | 2023-09-25 |
| P910007S062 | ARCHITECT Total PSA / Alinity i Total PSA | Abbott Laboratories | 2023-07-10 |
| P910007S061 | ARCHITECT Total PSA, Alinity i Total PSA | Abbott Laboratories | 2023-06-22 |
| P850048S059 | Access Hybritech PSA reagent pack | Beckman Coulter, Inc. | 2023-05-25 |
| P990056S039 | Elecsys total PSA, total PSA CalSet II | Roche Diagnostics Corp. | 2023-03-23 |
| P850048S057 | Access Hybritech PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2022-12-16 |
| P930027S028 | IMMULITE® /IMMULITE® 1000 PSA, IMMULITE® 2000 PSA and IMMULITE® /IMMULITE® 1000 Third Generation PSA | Siemens Healthcare Diagnostics, Inc. | 2022-10-14 |
| P910007S058 | ARCHITECT Total PSA / Alinity i Total PSA | Abbott Laboratories | 2022-10-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15099590701673 | Access Hybritech PSA | Beckman Coulter, Inc. | 2025-05-30 |
| 07613336217665 | Elecsys Total PSA | Roche Diagnostics GmbH | 2024-10-24 |
| 00380740130411 | Alinity | Abbott Ireland Diagnostics | 2020-11-18 |
| 00380740130428 | Alinity | Abbott Ireland Diagnostics | 2020-11-18 |
| 00380740158316 | Alinity | Abbott Ireland Diagnostics | 2020-11-18 |
| 00380740158323 | Alinity | Abbott Ireland Diagnostics | 2020-11-18 |
| 07613336165980 | Elecsys total PSA | Roche Diagnostics GmbH | 2020-08-24 |
| 07613336165997 | Elecsys total PSA | Roche Diagnostics GmbH | 2020-08-24 |
| 07613336166000 | Elecsys total PSA | Roche Diagnostics GmbH | 2020-08-24 |
| 07613336167496 | total PSA CalSet II | Roche Diagnostics GmbH | 2020-08-24 |
| 04015630939824 | Elecsys total PSA | Roche Diagnostics GmbH | 2018-07-16 |
| 00630414598444 | Atellica IM Calibrator Q | Siemens Healthcare Diagnostics Inc. | 2017-12-27 |
| 00630414598451 | Atellica IM Calibrator Q | Siemens Healthcare Diagnostics Inc. | 2017-12-22 |
| 07613336154373 | Elecsys tPSA | Roche Diagnostics GmbH | 2017-09-29 |
| 07613336154380 | total PSA Calset II | Roche Diagnostics GmbH | 2017-09-29 |
| 07613336154366 | Elecsys tPSA | Roche Diagnostics GmbH | 2017-09-29 |
| 04015630920754 | Elecsys Total PSA CalSet II | Roche Diagnostics GmbH | 2014-12-18 |
| 00380740008994 | ARCHITECT | Abbott Ireland Diagnostics | 2014-11-18 |
| 00380740008987 | ARCHITECT | Abbott Ireland Diagnostics | 2014-11-18 |
| 00380740008963 | ARCHITECT | Abbott Ireland Diagnostics | 2014-11-18 |
| 00842768013874 | Dimension® clinical chemistry system TPSA Flex® reagent cartridge | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 00842768016660 | Dimension Vista® System TPSA Flex® Reagent Cartridge | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 00630414202921 | ADVIA Centaur® Systems, ACS:180® Systems Calibrator Q | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 00630414202938 | ADVIA Centaur® Systems. ACS:180® Systems Calibrator Q | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 03573026156985 | VIDAS® | BIOMERIEUX SA | 2014-09-23 |
| H628372001 | Access Hybritech PSA | Beckman Coulter, Inc. | 2014-09-16 |
| H628372051 | Access Hybritech PSA Calibrators | Beckman Coulter, Inc. | 2014-09-16 |
| H628372061 | Access Hybritech PSA Sample Diluent | Beckman Coulter, Inc. | 2014-09-16 |
| 04015630921515 | Elecsys Total PSA Immunoassay | Roche Diagnostics GmbH | 2014-09-10 |
| 04015630920877 | Elecsys Total PSA Immunoassay | Roche Diagnostics GmbH | 2014-09-01 |