5,774 results
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50ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
FDA 510(k)
FDA Class 2
·Medical Genetics
Tissue of Origin Test Kit-FFPE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CELLTRACKS AUTOPREP SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
FDA 510(k)
FDA Class 2
·Hematology
ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
FDA 510(k)
FDA Class 2
·Hematology
TAG-IT CYSTIC FIBROSIS KIT
FDA 510(k)
FDA Class 2
·Immunology
SYSMEX UF-100
FDA 510(k)
FDA Class 2
·Hematology
INVADER FACTOR V
FDA 510(k)
FDA Class 2
·Hematology
XTAG CF60 KIT V2
FDA 510(k)
FDA Class 2
·Immunology
INPLEX CF MOLECULAR TEST
FDA 510(k)
FDA Class 2
·Immunology
VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
FDA 510(k)
FDA Class 2
·Hematology
FACTOR II (PROTHROMBIN) G20210A KIT
FDA 510(k)
FDA Class 2
·Hematology
IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
FDA 510(k)
FDA Class 2
·Hematology
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
FDA 510(k)
FDA Class 2
·Hematology
GENASIS HIPATH IHC FAMILY
FDA 510(k)
FDA Class 2
·Hematology
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
FDA 510(k)
FDA Class 2
·Medical Genetics
EMB/MUELLER-HINTON AGAR
FDA 510(k)
FDA Class 2
·Microbiology
FORMA-FAS-TEST
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
FDA 510(k)
FDA Class 2
·Immunology
MammaPrint FFPE NGS Kit
FDA 510(k)
FDA Class 2
·Immunology