5,616 results
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49ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAMMAPRINT
FDA 510(k)
FDA Class 2
·Immunology
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
FDA 510(k)
FDA Class 2
·Medical Genetics
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).
FDA 510(k)
FDA Class 2
·Hematology
ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
FDA 510(k)
FDA Class 2
·Hematology
ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
FDA 510(k)
FDA Class 2
·Immunology
SYSMEX MODEL UF1000I
FDA 510(k)
FDA Class 2
·Hematology
MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
FDA 510(k)
FDA Class 2
·Hematology
CELLTRACKS AUTOPREP SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
FLAME PHOTOMETRY REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CEP 8 SPECTRUMORANGE DNA PROBE KIT
FDA 510(k)
FDA Class 2
·Immunology
PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
SCANSCOPE XT SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody
FDA 510(k)
FDA Class 2
·Immunology
CELLTRACKS ANALYZER II
FDA 510(k)
FDA Class 2
·Immunology
OncoMate MSI Dx Analysis System
FDA 510(k)
FDA Class 2
·Immunology
FORMACLEAR- & MULTIPLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800
FDA 510(k)
FDA Class 2
·Immunology
PAXGENE BLOOD RNA SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
FDA 510(k)
FDA Class 2
·Hematology