Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0

Dental Abutment Design Software For Dental Laboratory

FDA classification

FDA Class 2 ·Dental Abutment Design Software For Dental Laboratory

Tracheal Prosthesis With Cover Material Derived From Human Sources

FDA classification

FDA Class 2 ·Tracheal Prosthesis With Cover Material Derived From Human Sources

Closed Loop Auto Titration Device For Oral Appliances

FDA classification

FDA Class 2 ·Closed Loop Auto Titration Device For Oral Appliances

Spinal Muscular Atrophy Newborn Screening Test System

FDA classification

FDA Class 2 ·Spinal Muscular Atrophy Newborn Screening Test System

Artificial Chordae Tendineae Surgical Replacement System

FDA classification

FDA Class 2 ·Artificial Chordae Tendineae Surgical Replacement System

Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

FDA classification

FDA Class 2 ·Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

FDA classification

FDA Class 2 ·Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

FDA classification

FDA Class 2 ·Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

Automated Digital Image Manual Interpretation Microscope

FDA classification

FDA Class 2 ·Automated Digital Image Manual Interpretation Microscope

Bone Sonometer

FDA classification

FDA Class 2 ·Bone Sonometer

Novel Influenza A Virus, A/H5 Ns1 Protein

FDA classification

FDA Class 2 ·Novel Influenza A Virus, A/H5 Ns1 Protein

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL

Forceps, Biopsy, Electric, Reprocessed

FDA classification

FDA Class 2 ·Forceps, Biopsy, Electric, Reprocessed

Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

FDA classification

FDA Class 2 ·Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

Filler, Bone Void, Alterable Compound For Cranioplasty

FDA classification

FDA Class 2 ·Filler, Bone Void, Alterable Compound For Cranioplasty

Spinous Process Plate

FDA classification

FDA Class 2 ·Spinous Process Plate

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

FDA classification

FDA Class 2 ·Radiological Computer Assisted Detection/Diagnosis Software For Fracture

High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

FDA classification

FDA Class 2 ·High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

Mechanical Ventilator

FDA classification

FDA Class 2 ·Mechanical Ventilator