10,000 results · 159ms · Sources: EU EUDAMED, US FDA

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

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

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