4 results
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66ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·RESOLUTION ctDx FIRST
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Guardant360 CDx