ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000

FDA 510(k)

FDA Class 2 ·Neurology

MINI TELEMETRY SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN

FDA 510(k)

FDA Class 2 ·Microbiology

DELFIA DIGOXIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KIRSCHNER COMPRESSION HIP SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DMLC IV-ERGO

FDA 510(k)

FDA Class 2 ·Radiology

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

Bcr/Abl1 Monitoring Test

FDA classification

FDA Class 2 ·Bcr/Abl1 Monitoring Test

Jak2 Gene Mutation Detection Test

FDA classification

FDA Class 2 ·Jak2 Gene Mutation Detection Test