1,816 results
·
40ms
·
Sources: EU EUDAMED, US FDA
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·HC2 High-Risk HPV DNA Test and digene / HC2 HPV DNA Test
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·BVI 1% OVD (!% SODIUM HYALURONATE VICSCOELASTIC SURGICAL AID FLUID
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Oncomine Dx Target Test
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·EUFLEXXA (1% SODIUM HYALURONATE)
Assay, Genotyping, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·VERSANT HCV Genotype 2.0 Assay (LiPA)
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·QuantiFERON-TB Gold and QuantiFERON-TB Gold Plus
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Guardant360 CDx
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·RealTime IDH1
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Praxis Extended RAS Panel
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·RealTime IDH2
QBC STAR, Refurbished
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Drucker Diagnostics·1 device
QBC Capillary Centrifuge
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Drucker Diagnostics·2 devices
QBC STAR Tube
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Drucker Diagnostics·2 devices
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-AB-EBK PLUS ASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys HBeAg and PreciControl HBeAg
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
FDA Pre-Market Approval
FDA Class 3
·BIOTRIN PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-AB-COREK PLUS ASSAY
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Aptima HPV Assay