30 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Immunohistochemistry Assay, Antibody, Ki-67
FDA Pre-Market Approval
FDA Class 3
·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
Immunocytochemistry Assay, P16/Ki-67
FDA Pre-Market Approval
FDA Class 3
·CINtec PLUS Cytology
Immunocytochemistry Assay, P16/Ki-67
FDA Pre-Market Approval
FDA Class 3
·CINtec PLUS Cytology
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 ARTIFICIAL URINARY SPHINCTER
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 INFLATABLE PENILE PROSTHESIS
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
FDA Pre-Market Approval
FDA Class 3
·CURESIS PLASMA SEPARATOR
Test System, For Drugs Of Abuse
FDA Pre-Market Approval
FDA Class 3
·AWARE TEST SYSTEM
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
FDA Pre-Market Approval
FDA Class 3
·CURESIS PLASMA SEPARATOR
Immunohistochemistry Assay, Antibody, Ki-67
FDA classification
FDA Class 3
·Immunohistochemistry Assay, Antibody, Ki-67
Immunocytochemistry Assay, P16/Ki-67
FDA classification
FDA Class 3
·Immunocytochemistry Assay, P16/Ki-67