CELLTRACKA ANALYZER II

FDA 510(k)

FDA Class 2 ·Immunology

VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)

FDA 510(k)

FDA Class 2 ·Hematology

VIRTUOSO SYSTEM FOR IHC P53 (DO-7)

FDA 510(k)

FDA Class 2 ·Hematology

ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

SAC-CEL

FDA 510(k)

FDA Class 2 ·Immunology

DUET SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFIED THAYER MARTIN AGAR

FDA 510(k)

FDA Class 2 ·Microbiology

VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)

FDA 510(k)

FDA Class 2 ·Hematology

ULTRACLONE 05-100 GUINEA PIG RBC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CYTOSCAN(R) DX

FDA 510(k)

FDA Class 2 ·Immunology

CELLSEARCH CIRCULATING TUMOR CELL KIT

FDA 510(k)

FDA Class 2 ·Immunology

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

INVADER MTHFR 677

FDA 510(k)

FDA Class 2 ·Hematology

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

FDA 510(k)

FDA Class 2 ·Medical Genetics