Xpert® Xpress CoV-2 plus

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)

FDA 510(k)

FDA Class 2 ·Microbiology

Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit

FDA 510(k)

FDA Class 2 ·Microbiology

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire COVID-19 Test 2

FDA 510(k)

FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire COVID-19 Test 2

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima SARS-CoV-2 Assay

FDA 510(k)

FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa COVID-19 Direct

FDA 510(k)

FDA Class 2 ·Microbiology

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

FDA classification

FDA Class 2 ·Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

EXTRAFIX EXTERNAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Curing Light, Model: MaxCure 9

FDA 510(k)

FDA Class 2 ·Dental

Ultrasonic Scaler Tips

FDA 510(k)

FDA Class 2 ·Dental

QUEX ED; QUEX S

FDA 510(k)

FDA Class 2 ·Neurology

EC50 MICRO+ SMOKERLYZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQCross Qx Integrated Transseptal Dilator/Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQCross Qx Integrated Transseptal Dilator/Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular