288 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
FDA Pre-Market Approval
FDA Class 3
·VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE TAG THORACIC ENDOPROSTHESIS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·DIASORIN ETI-MAK-2 PLUS
Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
FDA Pre-Market Approval
FDA Class 3
·Vysis ALK Break Apart Fish Probe Kit
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3) CDX ASSAY
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·MFK IOL
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3)
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3) CDx Assay
Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
FDA Pre-Market Approval
FDA Class 3
·VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3) CDX ASSAY
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3) CDX ASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·DIASORIN ETI MAK-2 PLUS ASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-MAK-2PLUS & ETI-MAK-2 PLUS HBSAG CONFIRMATORY TEST KIT
Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
FDA Pre-Market Approval
FDA Class 3
·VYSIS ALK BREAK APART FISH PROBE KIT
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·DIASORIN ETI-MAK-2PLUS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-MAK-2 PLUS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-MAK-2 PLUS
System, Test, Her-2/Neu, Nucleic Acid Or Serum
FDA Pre-Market Approval
FDA Class 3
·PATH VYSION HER-2 DNA PROBE KIT
Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
FDA Pre-Market Approval
FDA Class 3
·VYSIS ALK BREAK APART FISH PROBE KIT
Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
FDA Pre-Market Approval
FDA Class 3
·VYSIS ALK BREAK APART FISH PROBE KIT AND PROBECHEK ALK NEGATIVE CONTROL SLIDES