Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER M1000 SYSTEM

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·INDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·OMNISENSE 7000S ULTRASOUND BONE SONOMETER

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE

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

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·AFFINITY ANTERIOR CERVICAL CAGE SYSTEM

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

Medication Management System, Remote

FDA classification

FDA Class 2 ·Medication Management System, Remote

Radiant Infant Warmer Cabinet

FDA classification

FDA Class 2 ·Radiant Infant Warmer Cabinet

Interactive Rehabilitation Exercise Device, Prescription Use

FDA classification

FDA Class 2 ·Interactive Rehabilitation Exercise Device, Prescription Use

Software For Endoscopy Procedure Metrics

FDA classification

FDA Class 2 ·Software For Endoscopy Procedure Metrics

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR