3,053 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT TOTAL PSA (LN 6C06)
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Complexed PSA (cPSA) Assay
P2psa
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH P2SA REAGENTS ON THE ACCESS IMMUNCASSAY SYSTEM
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Alinity i Free PSA Reagent Kit
P2psa
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ELECSYS TOTAL PSA
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
P2psa
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AFP ASSAY (LN 3P36)
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·VIDAS TOTAL PSA
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Elecsys Total PSA, Total PSA CalSet ll
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AFP
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·IMMULITE 2000 Prostate-Specific Antigen (PSA)
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT TOTAL PSA
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Elecsys free PSA Test System, Biotin remediation
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·IMMULITE FPSA ASSAY
Generator, Shock-Wave, For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·HEALTHTRONICS OSSATRON
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