Simplexa COVID-19 Positive Control Pack

FDA UDI

DIASORIN MOLECULAR LLC·20816101027037·

COVID-19 Coronavirus Real Time PCR Kit

FDA UDI

Jiangsu Bioperfectus Technologies Co., Ltd.·06973342000158·

cobas® SARS-CoV-2 Qualitative 480T

FDA UDI

Roche Molecular Systems, Inc.·00875197006933·

BioFire® COVID-19 Test 2

FDA UDI

BIOFIRE DEFENSE, LLC·00851458005235·BioFire® COVID-19 Test 2 - IVD reagent kit cont...

cobas® SARS-CoV-2 Qualitative 192T

FDA UDI

Roche Molecular Systems, Inc.·00875197006841·

GeneXpert®

FDA UDI

CEPHEID·07332940008581·Xpert® Xpress CoV-2 plus

COVID-19 Coronavirus Real Time PCR Kit

FDA UDI

Jiangsu Bioperfectus Technologies Co., Ltd.·06973342000530·

Aptima SARS-CoV-2 Assay

FDA registration

HOLOGIC, LTD.·2 products·🇬🇧 United Kingdom

BD Respiratory Viral Panel-SCV2 for BD MAX System

FDA registration

BECTON, DICKINSON & CO.·2 products·🇺🇸 United States

BD Respiratory Viral Panel-SCV2 for BD MAX System

FDA registration

GeneOhm Sciences Canada, ULC.·2 products·🇨🇦 Canada

Aptima SARS-CoV-2 Assay

FDA registration

Hologic, Inc.·2 products·🇺🇸 United States

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