Assay, Proliferation, In Vitro, T Lymphocyte

FDA classification

FDA Class 2 ·Assay, Proliferation, In Vitro, T Lymphocyte

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

FDA classification

FDA Class 2 ·Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

Isocapnic Ventilation Device

FDA classification

FDA Class 2 ·Isocapnic Ventilation Device

Zinc Transporter 8 Auto-Antibody

FDA classification

FDA Class 2 ·Zinc Transporter 8 Auto-Antibody

Enzyme Immunoassay, Cortisol, Salivary

FDA classification

FDA Class 2 ·Enzyme Immunoassay, Cortisol, Salivary

Cream For X-Ray Attenuation

FDA classification

FDA Class 2 ·Cream For X-Ray Attenuation

Orthosis, Cranial, Laser Scan

FDA classification

FDA Class 2 ·Orthosis, Cranial, Laser Scan

Closed Loop Auto Titration Device For Oral Appliances

FDA classification

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

Adjunctive Pain Measurement Device For Anesthesiology

FDA classification

FDA Class 2 ·Adjunctive Pain Measurement Device For Anesthesiology

21-Hydroxylase Antibody (21-Ohab)

FDA classification

FDA Class 2 ·21-Hydroxylase Antibody (21-Ohab)

Conformal Brachytherapy Source

FDA classification

FDA Class 2 ·Conformal Brachytherapy Source

Instrumentation For Clinical Multiplex Test Systems

FDA classification

FDA Class 2 ·Instrumentation For Clinical Multiplex Test Systems

Micro Total Analysis Instrument System

FDA classification

FDA Class 2 ·Micro Total Analysis Instrument System

Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

FDA classification

FDA Class 2 ·Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

Antigen, Invasive Fungal Pathogens

FDA classification

FDA Class 2 ·Antigen, Invasive Fungal Pathogens

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

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

FDA classification

FDA Class 2 ·Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

Hospital Cardiac Telemetry

FDA classification

FDA Class 2 ·Hospital Cardiac Telemetry

Software For Endoscopy Procedure Metrics

FDA classification

FDA Class 2 ·Software For Endoscopy Procedure Metrics