Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen BRAF V600E RGQ PCR Kit

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart Fish Probe Kit

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MODEL 7421 ITREL 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION (SCS) SYSTEM

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval

FDA Class 3 ·T-SPOT TB TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS KRAS MUTATION TEST

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·ADEZA FETAL FIBRONECTIN EIK

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·BIOTRIN PARVOVIRUS IGM EIA (V619IMUS)

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·SPOT-LIGHT HER2 CISH KIT

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AUTODELFIA XPRESS HAFP TEST SYSTEM

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY HER-2/NEU (CLONE CD11) PRIMARY ANTIBODY

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AXSYM FREE PSA ASSAY

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4® PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL 4 IMPLANTABLE NEUROSTIMULATION SYSTEM

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 PHARMDX

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·INSITE HER-2/NEU KIT