6,316 results · 48ms · Sources: EU EUDAMED, US FDA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT HBSAG/CONFIRMATORY

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval
FDA Class 3 ·IMMUNOCYTOCHEMICAL ASSAY TO DETECT PROGESTERONE

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT CORE / Alinity i Anti-HBc

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT AUSAB / Alinity i Anti-HBs

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT IMX AFP ASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT FREE PSA AND AXSYM FREE PSA

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·AXSYM ANTI-HCV

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT HBSAG/CONFIMATORY

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT AFP-EIA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT AUSAB (LN 1L82)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ARCHITECT ANTI-HCV

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT Free PSA / Alinity i Free PSA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT HBSAG/CONFIRMATORY

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval
FDA Class 2 ·ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT CORE-M

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ARCHITECT ANTI-HCV

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT FREE PSA

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·AXSYM ANTI-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·AXSYM ANTIBODY TO HCV