Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

FDA classification

FDA Class 2 ·Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer

FDA classification

FDA Class 2 ·System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

FDA classification

FDA Class 2 ·Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Container, Empty, For Collection & Processing Of Blood & Blood Components

FDA classification

FDA Class 2 ·Container, Empty, For Collection & Processing Of Blood & Blood Components

Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

FDA classification

FDA Class 2 ·Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA classification

FDA Class 3 ·Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

FDA classification

FDA Class 2 ·Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera

FDA classification

FDA Class 2 ·Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera

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

Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19

FDA classification

FDA Not Classified ·Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19

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

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

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

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

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

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

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

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