Product code MTG
- Device name
- Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- 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 |
|---|---|---|---|
| P250026 | Atellica IM free PSA II (fPSAII) | Siemens Healthcare Diagnostics, Inc. | 2026-05-11 |
| P060005S024 | IMMULITE 2000 Free PSA | Siemens Medical Solutions Diagnostics Limited | 2026-04-21 |
| P980007S056 | ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) | Abbott Laboratories | 2026-02-12 |
| P060005S023 | IMMULITE 2000 Free PSA | Siemens Medical Solutions Diagnostics Limited | 2025-10-30 |
| P060005S022 | IMMULITE 2000 Systems Free Prostate-Specific Antigen (Free PSA) | Siemens Medical Solutions Diagnostics Limited | 2025-08-14 |
| P950021S030 | ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA) | Siemens Healthcare Diagnostics | 2025-07-16 |
| P970038S046 | Access Hybritech free PSA | Beckman Coulter, Inc. | 2025-05-15 |
| P980007S055 | ARCHITECT Free PSA / Alinity i Free PSA | Abbott Laboratories | 2025-04-03 |
| P020027S041 | Dimension FPSA Flex reagent cartridge | Siemens Healthcare Diagnostics | 2025-02-24 |
| P000027S040 | Elecsys free PSA Test System | Roche Diagnostics Corp. | 2024-10-17 |
| P950021S029 | Atellica IM Prostate-Specific Antigen (PSA) | Siemens Healthcare Diagnostics | 2024-09-23 |
| P950021S026 | Atelica IM Prostate-Specific Antigen (PSA) | Siemens Healthcare Diagnostics | 2024-05-15 |
| P950021S027 | ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA | Siemens Healthcare Diagnostics | 2023-12-18 |
| P980007S054 | ARCHITECT Free PSA / Alinity i Free PSA | Abbott Laboratories | 2023-12-14 |
| P980007S053 | Alinity i Free PSA Reagent Kit | Abbott Laboratories | 2023-11-08 |
| P020027S040 | Dimension® FPSA Flex® reagent cartridge | Siemens Healthcare Diagnostics | 2023-09-26 |
| P980007S052 | Alinity i Free PSA | Abbott Laboratories | 2023-09-25 |
| P060005S015 | IMMULITE® 1000 Free PSA, IMMULITE® 2000 Free PSA | Siemens Medical Solutions Diagnostics Limited | 2023-08-30 |
| P980007S051 | ARCHITECT Free PSA / Alinity i Free PSA | Abbott Laboratories | 2023-07-10 |
| P980007S050 | ARCHITECT Free PSA, Alinity i Free PSA | Abbott Laboratories | 2023-06-22 |
| P000027S037 | Elecsys free PSA, free PSA CalSet | Roche Diagnostics Corp. | 2023-03-23 |
| P970038S045 | Access Hybritech Free PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2022-12-16 |
| P060005S016 | IMMULITE® /IMMULITE® 1000 Free PSA and IMMULITE® 2000 Free PSA | Siemens Medical Solutions Diagnostics Limited | 2022-10-14 |
| P980007S047 | ARCHITECT Free PSA / Alinity i Free PSA | Abbott Laboratories | 2022-10-12 |
| P950021S025 | Atellica® IM Prostate-Specific Antigen (PSA) Assay | Siemens Healthcare Diagnostics | 2022-03-29 |
| P020027S039 | Dimension® FPSA Flex® reagent cartridge | Siemens Healthcare Diagnostics | 2021-12-20 |
| P980007S046 | ARCHITECT Free PSA / Alinity i Free PSA | Abbott Laboratories | 2021-12-15 |
| P980007S045 | ARCHITECT Free PSA (LN 6C07) | Abbott Laboratories | 2021-12-06 |
| P020027S037 | Dimension Vista FPSA Flex reagent cartridge | Siemens Healthcare Diagnostics | 2021-10-08 |
| P060005S013 | IMMULITE / IMMULITE 1000 FREE PSA | Siemens Medical Solutions Diagnostics Limited | 2021-04-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15099590701680 | Access Hybritech free PSA | Beckman Coulter, Inc. | 2025-05-30 |
| 00380740130305 | Alinity | Abbott Ireland Diagnostics | 2020-11-18 |
| 00380740130312 | Alinity | Abbott Ireland Diagnostics | 2020-11-18 |
| 00380740158330 | Alinity | Abbott Ireland Diagnostics | 2020-11-18 |
| 00380740158347 | Alinity | Abbott Ireland Diagnostics | 2020-11-18 |
| 07613336166673 | Elecsys free PSA | Roche Diagnostics GmbH | 2020-08-27 |
| 07613336168134 | free PSA CalSet | Roche Diagnostics GmbH | 2020-08-26 |
| 07613336166628 | Elecsys free PSA | Roche Diagnostics GmbH | 2020-08-26 |
| 04015630940011 | Elecsys free PSA | Roche Diagnostics GmbH | 2018-08-23 |
| 07613336154403 | free PSA CalCheck | Roche Diagnostics GmbH | 2018-06-29 |
| 07613336155400 | free PSA Calset | Roche Diagnostics GmbH | 2017-09-29 |
| 07613336154397 | Elecsys free PSA | Roche Diagnostics GmbH | 2017-09-29 |
| 04015630997053 | Elecsys Free PSA CalCheck | Roche Diagnostics GmbH | 2014-12-18 |
| 00380740009007 | ARCHITECT | Abbott Ireland Diagnostics | 2014-11-18 |
| 00380740009014 | ARCHITECT | Abbott Ireland Diagnostics | 2014-11-18 |
| 00380740009021 | ARCHITECT | Abbott Ireland Diagnostics | 2014-11-18 |
| 00842768013751 | Dimension® clinical chemistry system T/F PSA Calibrator | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 00842768013881 | Dimension® clinical chemistry system FPSA Flex® reagent cartridge | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 00842768016677 | Dimension Vista® System FPSA Flex® Reagent Cartridge | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 00842768024214 | Dimension Vista® System PSA CAL | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 00630414971575 | IMMULITE®/IMMULITE®1000 Systems fPS Free PSA | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2014-09-24 |
| 00630414977478 | IMMULITE® 2000 Systems fPS Free PSA | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2014-09-24 |
| H628372101 | Access Hybritech free PSA | Beckman Coulter, Inc. | 2014-09-16 |
| H628372151 | Access Hyritech free PSA Calibrators | Beckman Coulter, Inc. | 2014-09-16 |
| 04015630919338 | Elecsys Free PSA CalSet | Roche Diagnostics GmbH | 2014-09-10 |
| 04015630919321 | Elecsys Free PSA Immunoassay | Roche Diagnostics GmbH | 2014-09-09 |