739 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·IMMULITE FPSA ASSAY
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·SIEMENS IMMULITE PSA AND THIRD GENERATION PSA ASSAYS ON THE IMMULITE, IMMULITE 1000, 2000 AND IMMULITE 2500 ANALYZERS
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSIONS TPSA FLE REAGENT CARTRIDGE
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT FREE PSA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Dimension FPSA Flex reagent cartridge (RF452)
System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·NMP22 BLADDERCHEK TEST KIT
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC-IGM
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMUNOASSAY SYSTEMS
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA
P2psa
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IGM IMMUNOASSAY
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur PSA Readypack Reagents
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR CPSA ASSAY
System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·NMP22 BLADDERCHEK TEST
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT Total PSA Reagent Kit, Alinity i Total PSA Reagent Kit
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Dimension Vista FPSA Flex reagent cartridge
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS