5,564 results
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48ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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CELLTRACKS ANALYER II
FDA 510(k)
FDA Class 2
·Immunology
VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)
FDA 510(k)
FDA Class 2
·Hematology
ipsogen JAK2 RGQ PCR Kit
FDA 510(k)
FDA Class 2
·Medical Genetics
OMNYX IDP FOR HER2 MANUAL APPLICATION
FDA 510(k)
FDA Class 2
·Hematology
KARYOTEC 100
FDA 510(k)
FDA Class 2
·Hematology
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
FDA 510(k)
FDA Class 2
·Hematology
MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
FDA 510(k)
FDA Class 2
·Hematology
ARIOL
FDA 510(k)
FDA Class 2
·Hematology
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67
FDA 510(k)
FDA Class 2
·Hematology
SCANSCOPE XT SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)
FDA 510(k)
FDA Class 2
·Hematology
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
FDA 510(k)
FDA Class 2
·Immunology
HEPAQUANT
FDA 510(k)
FDA Class 2
·Hematology
SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL
FDA 510(k)
FDA Class 2
·Immunology
MAMMAPRINT
FDA 510(k)
FDA Class 2
·Immunology
Kolplast Cervical Sample Collection Kit
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
FDA 510(k)
FDA Class 2
·Hematology
ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8
FDA 510(k)
FDA Class 2
·Immunology