Tissue of Origin Test Kit-FFPE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CELLTRACKS AUTOPREP SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

VIRTUOSO SYSTEM FOR IHC HER2 (4B5)

FDA 510(k)

FDA Class 2 ·Hematology

ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

FDA 510(k)

FDA Class 2 ·Hematology

TAG-IT CYSTIC FIBROSIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

SYSMEX UF-100

FDA 510(k)

FDA Class 2 ·Hematology

INVADER FACTOR V

FDA 510(k)

FDA Class 2 ·Hematology

XTAG CF60 KIT V2

FDA 510(k)

FDA Class 2 ·Immunology

INPLEX CF MOLECULAR TEST

FDA 510(k)

FDA Class 2 ·Immunology

VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)

FDA 510(k)

FDA Class 2 ·Hematology

FACTOR II (PROTHROMBIN) G20210A KIT

FDA 510(k)

FDA Class 2 ·Hematology

IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE

FDA 510(k)

FDA Class 2 ·Hematology

CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY

FDA 510(k)

FDA Class 2 ·Hematology

GENASIS HIPATH IHC FAMILY

FDA 510(k)

FDA Class 2 ·Hematology

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