MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

FDA 510(k)

FDA Class 2 ·Medical Genetics

EMB/MUELLER-HINTON AGAR

FDA 510(k)

FDA Class 2 ·Microbiology

FORMA-FAS-TEST

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

MammaPrint FFPE NGS Kit

FDA 510(k)

FDA Class 2 ·Immunology

IQ 200 SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

MammaPrint

FDA 510(k)

FDA Class 2 ·Immunology

FLEXMAP 3D

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS

FDA 510(k)

FDA Class 2 ·Hematology

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)

FDA 510(k)

FDA Class 2 ·Hematology

HISTOSET IMMUNOPEROFIDASE TISSUE

FDA 510(k)

FDA Class 2 ·Microbiology

VIRTUOSO SYSTEM FOR IHC PR (IE2)

FDA 510(k)

FDA Class 2 ·Hematology

ARIOL HER-2/NEU FISH

FDA 510(k)

FDA Class 2 ·Immunology

ANEUVYSION MULITICOLOR DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-CYTOKERATIN MONOCLONAL ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS

FDA 510(k)

FDA Class 2 ·Hematology

NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.

FDA 510(k)

FDA Class 2 ·Hematology

HILAR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry