Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

FDA classification

FDA Class 2 ·Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

FDA classification

FDA Class 2 ·Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

Defect Measurement Tool

FDA classification

FDA Class 2 ·Defect Measurement Tool

Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

FDA classification

FDA Not Classified ·Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification

FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

Reagents For Molecular Diagnostic Test Systems

FDA classification

FDA Class 1 ·Reagents For Molecular Diagnostic Test Systems

System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home

FDA classification

FDA Class 2 ·System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home

Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

FDA classification

FDA Class 2 ·Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

Self-Fitting Air-Conduction Hearing Aid, Prescription

FDA classification

FDA Class 2 ·Self-Fitting Air-Conduction Hearing Aid, Prescription

Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

FDA classification

FDA Not Classified ·Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

Computerized Cognitive Assessment Aid

FDA classification

FDA Class 2 ·Computerized Cognitive Assessment Aid

Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

FDA classification

FDA Class 3 ·Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)

FDA classification

FDA Not Classified ·Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)

Device To Detect Microbial Colonization Directly From Clinical Specimens.

FDA classification

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

Alternate Controller Enabled Insulin Infusion Pump

FDA classification

FDA Class 2 ·Alternate Controller Enabled Insulin Infusion Pump

Evoked Photon Image Capture Device

FDA classification

FDA Class 1 ·Evoked Photon Image Capture Device

Self-Fitting Air-Conduction Hearing Aid, Over The Counter

FDA classification

FDA Class 2 ·Self-Fitting Air-Conduction Hearing Aid, Over The Counter

Outpatient Cardiac Telemetry

FDA classification

FDA Class 2 ·Outpatient Cardiac Telemetry