xTAG Gastrointestinal Pathogen Panel (GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

MolecuLight I:X

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

XTAG RESPIRATORY VIRAL PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software

FDA 510(k)

FDA Class 2 ·Microbiology

ClearMate

FDA 510(k)

FDA Class 2 ·General Hospital

Radioimmunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·CYCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS

Radioimmunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·1YCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS

System, Intrafallopian Cannula

FDA classification

FDA Class 2 ·System, Intrafallopian Cannula

Assisted Reproduction Laminar Flow Workstation

FDA classification

FDA Class 2 ·Assisted Reproduction Laminar Flow Workstation

Accessory, Assisted Reproduction, Exempt

FDA classification

FDA Class 2 ·Accessory, Assisted Reproduction, Exempt

Dna And Rna Oncology Controls

FDA classification

FDA Class 2 ·Dna And Rna Oncology Controls

Hematopoietic Cell Enrichment Kit

FDA classification

FDA Class 2 ·Hematopoietic Cell Enrichment Kit

Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit

FDA classification

FDA Class 2 ·Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit

Spinal Muscular Atrophy Newborn Screening Test System

FDA classification

FDA Class 2 ·Spinal Muscular Atrophy Newborn Screening Test System

Quality Control Material, Genetics, Rna

FDA classification

FDA Class 2 ·Quality Control Material, Genetics, Rna

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

FDA classification

FDA Class 2 ·Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

Cancer Predisposition Risk Assessment System

FDA classification

FDA Class 2 ·Cancer Predisposition Risk Assessment System

Whole Exome Sequencing Constituent Device

FDA classification

FDA Class 2 ·Whole Exome Sequencing Constituent Device

Hiv-1 Genotyping Assay Using Ngs Technology

FDA classification

FDA Class 2 ·Hiv-1 Genotyping Assay Using Ngs Technology

Direct-To-Consumer Access Pharmacogenetic Assessment System

FDA classification

FDA Class 2 ·Direct-To-Consumer Access Pharmacogenetic Assessment System