QIAstat-Dx Respiratory Panel Mini

FDA 510(k)

FDA Class 2 ·Microbiology

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

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·AL-47 SOFT CONTACT LENS

SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Bioliner

FDA 510(k)

FDA Class 2 ·Dental

Qmenta Care Platform Family

FDA 510(k)

FDA Class 2 ·Radiology

Emerald Herbst

FDA 510(k)

FDA Class 2 ·Dental

AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE

FDA 510(k)

FDA Class 2 ·Ophthalmic

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