cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

FDA 510(k)

FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology

BinaxNOW COVID-19 Ag Card

FDA 510(k)

FDA Class 2 ·Microbiology

BD Veritor System for SARS-CoV-2

FDA 510(k)

FDA Class 2 ·Microbiology

SCoV-2 Ag Detect Rapid Test

FDA 510(k)

FDA Class 2 ·Microbiology

Healgen Rapid COVID-19 Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 v2 nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology

Nano-Check™ COVID-19 Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

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 HCV TEST

Accessory To Continuous Ventilator (Respirator)

FDA classification

FDA Class 2 ·Accessory To Continuous Ventilator (Respirator)

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

Pericardial Patch To Facilitate Revision Surgeries

FDA classification

FDA Class 2 ·Pericardial Patch To Facilitate Revision Surgeries

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

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

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