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

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

FDA Pre-Market Approval

FDA Class 3 ·Vivistim System

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT TOTAL PSA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP IMMUNOASSAY SYSTEM

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

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AFP / Alinity i AFP

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT TOTAL PSA (LN 6C06)

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE® /IMMULITE® 1000 AFP and IMMULITE® 2000 AFP

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS FREE PSA CALSET

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 ·Atellica IM Prostate-Specific Antigen (PSA)

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE AFP AND IMMULITE 2000 AFP

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·Elecsys total PSA Test System

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·AXSYM FREE PSA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Alinity i AFP 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 ·DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur (XP/XPT, CP) AFP; Atellica IM AFP

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 Free PSA and IMMULITE 2000 Free PSA