914 results · 39ms · Sources: EU EUDAMED, US FDA

ROSS EMBRACE ENTERAL PUMP

FDA 510(k)
FDA Class 2 ·General Hospital

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME CMV

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT IMX(R) HAVAB(R)-M

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

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

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

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

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT HAVAB/HAVAB EIA/IMX HAVAB

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·HAVAB

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·MURINE CONTACT LENS CLEANER

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM/TOTAL PSA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

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

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM HAVAB 2.0

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

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

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval
FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

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

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM AFP

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·HAVAB-M DIAGNOSTIC KIT

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

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

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM TOTAL PSA