394 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·4Kscore Test
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·IMMULITE/IMMULITE 1000 THIRD GENERATION PSA
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·BAYER IMMUNO 1 COMPLEXED PSA ASSAY
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Complexed PSA (cPSA) Assay
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·IMMULITE 2000 Prostate-Specific Antigen (PSA)
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·BAYER ADVIA IMS COMPLEXED PSA ASSAY
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Complexed PSA (cPSA) Assay
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Prostate-Specific Antigen (PSA)
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH FREE PSA REAGENT ASSAY
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Complexed PSA (cPSA) Assay
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR PSA & CPSA ASSAYS
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Prostate-Specific Antigen (PSA)
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur and Atellica IM PSA
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM
P2psa
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS
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 AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Prostate-Specific Antigen (PSA) Assay
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Prostate-Specific Antigen (PSA) Assay