504 results · 21ms · Sources: EU EUDAMED, US FDA

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Alinity m CMV Assay

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

FDA Pre-Market Approval
FDA Class 2 ·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS

Fluorescence Polarization Immunoassay For Cyclosporine

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

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

FDA Pre-Market Approval
FDA Class 2 ·IMX AND AXSYM PSA

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

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

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·IMX HAVAB-M

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT IMX HAVAB-M LIST 2263

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 ·IMX HAVAB

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

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

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval
FDA Class 2 ·MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·ACS RX PERFUSION CORON. DILATION CATHETER ADD 2.0

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval
FDA Class 2 ·KENTROX RV-S/KENTROX SL-S ICD LEADS

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

FDA Pre-Market Approval
FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Alinity m CMV Assay

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·MENICON SF-P (TM)

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

FDA Pre-Market Approval
FDA Class 2 ·Dimension TPSA Flex Reagent Cartridge

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·SENOGRAPHE DS & 2000D FFDM SYSTEM

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLIPREP/COMBAS TAQMAN HCV TEST V2.0