Nano-Check™ COVID-19 Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS HCV TEST

Oximeter To Measure Hemoglobin

FDA classification

FDA Class 2 ·Oximeter To Measure Hemoglobin

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0

Accessory To Continuous Ventilator (Respirator)

FDA classification

FDA Class 2 ·Accessory To Continuous Ventilator (Respirator)

Pericardial Patch To Facilitate Revision Surgeries

FDA classification

FDA Class 2 ·Pericardial Patch To Facilitate Revision Surgeries

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·APTIMA HCV QUANT DX ASSAY

Hyperoxia Monitoring Device Adjunct To Pulse Oximetry

FDA classification

FDA Class 2 ·Hyperoxia Monitoring Device Adjunct To Pulse Oximetry

Electrical Tongue Stimulator To Treat Motor Deficits

FDA classification

FDA Class 2 ·Electrical Tongue Stimulator To Treat Motor Deficits

Direct-To-Consumer Access Pharmacogenetic Assessment System

FDA classification

FDA Class 2 ·Direct-To-Consumer Access Pharmacogenetic Assessment System

Adaptor To The Cord, For Transurethral Surgical Instrument

FDA classification

FDA Class 2 ·Adaptor To The Cord, For Transurethral Surgical Instrument

Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms

FDA classification

FDA Class 2 ·Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms

String And Tubes, Gastrointestinal, To Locate Internal Bleeding

FDA classification

FDA Class 2 ·String And Tubes, Gastrointestinal, To Locate Internal Bleeding

Bone Marrow Processing Device To Support Hematopoietic Reconstitution

FDA classification

FDA Class 2 ·Bone Marrow Processing Device To Support Hematopoietic Reconstitution

Vessel Guard Or Cover, To Facilitate Revision Surgeries

FDA classification

FDA Class 2 ·Vessel Guard Or Cover, To Facilitate Revision Surgeries

Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

FDA classification

FDA Class 2 ·Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

Software Algorithm Device To Assist Users In Digital Pathology

FDA classification

FDA Class 2 ·Software Algorithm Device To Assist Users In Digital Pathology

Radiological Software Device To Predict Future Breast Cancer Risk

FDA classification

FDA Class 2 ·Radiological Software Device To Predict Future Breast Cancer Risk

Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor

FDA classification

FDA Class 2 ·Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor

Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

FDA classification

FDA Class 2 ·Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety