ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800

FDA 510(k)

FDA Class 2 ·Immunology

VIRTUOSO SYSTEM FOR IHC ER (SPI)

FDA 510(k)

FDA Class 2 ·Hematology

PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ACLAIMS-IS

FDA 510(k)

FDA Class 2 ·Hematology

DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR

FDA 510(k)

FDA Class 2 ·Hematology

ALBUMIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TAG-IT CYSTIC FIBROSIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

FDA 510(k)

FDA Class 2 ·Medical Genetics

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

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

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