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

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

Air-Conduction Hearing Aid Software

FDA classification

FDA Class 2 ·Air-Conduction Hearing Aid Software

Magnetic Compression Anastomosis System

FDA classification

FDA Class 2 ·Magnetic Compression Anastomosis System

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

FDA classification

FDA Class 2 ·Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Mass Spectrometer For Clinical Multiplex Test Systems

FDA classification

FDA Class 2 ·Mass Spectrometer For Clinical Multiplex Test Systems

Device To Detect Microbial Colonization Directly From Clinical Specimens.

FDA classification

FDA Class 2 ·Device To Detect Microbial Colonization Directly From Clinical Specimens.

Extracorporeal System For Carbon Dioxide Removal

FDA classification

FDA Class 2 ·Extracorporeal System For Carbon Dioxide Removal

Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

FDA classification

FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

FDA classification

FDA Class 2 ·Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

Containment System, Laparoscopic Power Morcellation, With Instrument Port

FDA classification

FDA Class 2 ·Containment System, Laparoscopic Power Morcellation, With Instrument Port

Camera, Ophthalmic, General-Use

FDA classification

FDA Class 2 ·Camera, Ophthalmic, General-Use

Inherited Nucleotide Repeat Disorder Dna Test

FDA classification

FDA Class 2 ·Inherited Nucleotide Repeat Disorder Dna Test

Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity

FDA classification

FDA Class 2 ·Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity

Immunohistochemistry Antibody Assay, Estrogen Receptor

FDA classification

FDA Class 2 ·Immunohistochemistry Antibody Assay, Estrogen Receptor