BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Pneumonia Panel plus

FDA 510(k)

FDA Class 2 ·Pathology

Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Sars-Cov-2 Serology Test

FDA classification

FDA Class 2 ·Sars-Cov-2 Serology Test

Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

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

Anchor, Suture, Bone Fixation, Metallic

FDA classification

FDA Class 2 ·Anchor, Suture, Bone Fixation, Metallic

Catheters, Salpingography

FDA classification

FDA Class 2 ·Catheters, Salpingography

ID NOW COVID-19 2.0

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

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

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

Peripheral Intravenous (Piv) Infiltration Monitor

FDA classification

FDA Class 2 ·Peripheral Intravenous (Piv) Infiltration Monitor

Over-The-Counter Covid-19 Antigen Test

FDA classification

FDA Class 2 ·Over-The-Counter Covid-19 Antigen Test

Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

FDA classification

FDA Class 2 ·Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

FDA classification

FDA Class 2 ·Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings