Lens, Contact, For Reading Discomfort

FDA classification

FDA Class 2 ·Lens, Contact, For Reading Discomfort

Setmelanotide Eligibility Gene Variant Detection System

FDA classification

FDA Class 2 ·Setmelanotide Eligibility Gene Variant Detection System

Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

FDA classification

FDA Class 2 ·Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

Immunoassay Blood Test For Amyloid Pathology Assessment

FDA classification

FDA Class 2 ·Immunoassay Blood Test For Amyloid Pathology Assessment

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

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

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK

Assay, Enterovirus Nucleic Acid

FDA classification

FDA Class 2 ·Assay, Enterovirus Nucleic Acid

System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

FDA classification

FDA Class 2 ·System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

FDA classification

FDA Class 2 ·Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

FDA classification

FDA Class 2 ·Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ARTUS CMV RGQ MDX KIT

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

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

Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

FDA classification

FDA Class 2 ·Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

Cardiac Allograft Gene Expression Profiling Test System

FDA classification

FDA Class 2 ·Cardiac Allograft Gene Expression Profiling Test System

Closed Loop Auto Titration Device For Oral Appliances

FDA classification

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

Biomicroscope, Slit-Lamp, Ac-Powered, Exempt

FDA classification

FDA Class 2 ·Biomicroscope, Slit-Lamp, Ac-Powered, Exempt

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

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

Over-The-Counter Device To Assess Risk Of Sleep Apnea

FDA classification

FDA Class 2 ·Over-The-Counter Device To Assess Risk Of Sleep Apnea

Mechanical Ventilator

FDA classification

FDA Class 2 ·Mechanical Ventilator