5,520 results
·
46ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
×
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
INVADER MTHFR 1298
FDA 510(k)
FDA Class 2
·Hematology
DAKO PAP KIT K504
FDA 510(k)
FDA Class 2
·Immunology
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