Organophosphate Test System

FDA classification

FDA Class 2 ·Organophosphate Test System

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification

FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Monitor, Extracellular Fluid, Lymphedema, Extremity

FDA classification

FDA Class 2 ·Monitor, Extracellular Fluid, Lymphedema, Extremity

Lynch Syndrome Test System

FDA classification

FDA Class 2 ·Lynch Syndrome Test System

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

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

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

Catheter, Peritoneal Dialysis, Single Use, Exempt

FDA classification

FDA Class 2 ·Catheter, Peritoneal Dialysis, Single Use, Exempt

Closed Loop Auto Titration Device For Oral Appliances

FDA classification

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

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

NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital