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Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA product code MTG · Class 3 · Unknown
26
Registered devices
117
Adverse events
3
Recalls
0
510(k) clearances
Devices with this code
Access Hybritech free PSA — Beckman Coulter, Inc.ARCHITECT — Abbott Ireland DiagnosticsAccess Hybritech free PSA — Beckman Coulter, Inc.Elecsys Free PSA Immunoassay — Roche Diagnostics GmbHIMMULITE®/IMMULITE®1000 Systems fPS Free PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAlinity — Abbott Ireland Diagnosticsfree PSA CalSet — Roche Diagnostics GmbHDimension Vista® System FPSA Flex® Reagent Cartridge — Siemens Healthcare Diagnostics Inc.Elecsys free PSA — Roche Diagnostics GmbHAlinity — Abbott Ireland DiagnosticsElecsys free PSA — Roche Diagnostics GmbHAlinity — Abbott Ireland DiagnosticsAlinity — Abbott Ireland DiagnosticsDimension® clinical chemistry system FPSA Flex® reagent cartridge — Siemens Healthcare Diagnostics Inc.Elecsys Free PSA CalCheck — Roche Diagnostics GmbHAccess Hyritech free PSA Calibrators — Beckman Coulter, Inc.Dimension Vista® System PSA CAL — Siemens Healthcare Diagnostics Inc.free PSA CalCheck — Roche Diagnostics GmbHElecsys Free PSA CalSet — Roche Diagnostics GmbHDimension® clinical chemistry system T/F PSA Calibrator — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott Ireland Diagnosticsfree PSA Calset — Roche Diagnostics GmbHElecsys free PSA — Roche Diagnostics GmbHIMMULITE® 2000 Systems fPS Free PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con |
| 2011-10-11 | Beckman Coulter Inc. | A recall was initiated because Beckman Coulter has confirmed a change to the recommended diluents for the Access Hybritech free PSA reagent. |
| 2008-01-08 | Beckman Coulter Inc | Beckman Coulter incorrectly shipped Access Hybritech free PSA calibrators containing dual calibration cards (Hybritech and WHO) to your lab. The WHO calibratio |
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