5,546 results
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47ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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939UDX URINE PATHOLOGY SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
FDA 510(k)
FDA Class 2
·Immunology
VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
FDA 510(k)
FDA Class 2
·Immunology
Her-2, ER, PR IHControls
FDA 510(k)
FDA Class 2
·Hematology
IMMUNOCYT
FDA 510(k)
FDA Class 2
·Hematology
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
FDA 510(k)
FDA Class 2
·Hematology
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
FDA 510(k)
FDA Class 2
·Immunology
VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU
FDA 510(k)
FDA Class 2
·Hematology
CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
FDA 510(k)
FDA Class 2
·Immunology
ANEUVYSION
FDA 510(k)
FDA Class 2
·Immunology
MAMMAPRINT FFPE
FDA 510(k)
FDA Class 2
·Immunology
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
FDA 510(k)
FDA Class 2
·Hematology
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
FDA 510(k)
FDA Class 2
·Hematology
VENTANA IMAGE ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
SCANSCOPE XT SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
LECTIN H
FDA 510(k)
FDA Class 2
·Hematology
CELLTRACKS ANALYZER II SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
STAT FIX MICROWAVE IRRADIATION MEDIUM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2)
FDA 510(k)
FDA Class 2
·Hematology
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020
FDA 510(k)
FDA Class 2
·Immunology