PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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

FDA 510(k)

FDA Class 2 ·Hematology

PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01

FDA 510(k)

FDA Class 2 ·General Hospital

BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16

FDA 510(k)

FDA Class 2 ·Hematology

CYTOLOGY BRUSH

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Idylla MSI Test

FDA 510(k)

FDA Class 2 ·Immunology

INFINITI SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BOND MMR Antibody Panel

FDA 510(k)

FDA Class 2 ·Immunology

ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

HEMACOUNT WRIGHT GIEMSA STAIN PACK

FDA 510(k)

FDA Class 2 ·Radiology

CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001

FDA 510(k)

FDA Class 2 ·Immunology

RNARETAIN

FDA 510(k)

FDA Class 2 ·Immunology

EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)

FDA 510(k)

FDA Class 2 ·Immunology

LAS-R HUMAN HAPTOGLOBIN TEST

FDA 510(k)

FDA Class 2 ·Immunology

DACOS PLUS LYTES OPTION

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GENASIS SCANVIEW SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67

FDA 510(k)

FDA Class 2 ·Hematology

PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AKS II

FDA 510(k)

FDA Class 2 ·Hematology