Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA classification

FDA Class 3 ·Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

FDA classification

FDA Class 2 ·Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

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

Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

FDA classification

FDA Class 2 ·Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

FDA classification

FDA Class 1 ·Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

FDA classification

FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria

FDA classification

FDA Not Classified ·Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria

Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus

FDA classification

FDA Class 2 ·Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FDA classification

FDA Class 2 ·Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices

FDA classification

FDA Class 2 ·Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

FDA classification

FDA Class 2 ·Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

FDA classification

FDA Unclassified ·Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

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

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA classification

FDA Class 3 ·Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

Led Lamps Emitting Visible Light Intended To Be Used For Illumination Purposes

FDA classification

FDA Not Classified ·Led Lamps Emitting Visible Light Intended To Be Used For Illumination Purposes

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA classification

FDA Class 3 ·Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led

FDA classification

FDA Not Classified ·System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led

Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

FDA classification

FDA Class 2 ·Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

FDA classification

FDA Class 1 ·Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)

FDA classification

FDA Unclassified ·Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)