Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

LIAISON PLEX Respiratory Flex Assay

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

ORTHODONTIC CERAMIC BRACKET

FDA 510(k)

FDA Class 2 ·Dental

SMR Reverse HP Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

ID NOW COVID-19 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

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

Sars-Cov-2 Serology Test

FDA classification

FDA Class 2 ·Sars-Cov-2 Serology Test

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

Fibrinogen And Split Products, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Fibrinogen And Split Products, Antigen, Antiserum, Control