QKO / Reagent, coronavirus serological

FDA registration

MONOCENT INC.·1 product·🇺🇸 United States

QKO (TM) AMYLASE B-HA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Anti-SARS-CoV-2 PC Elecsys

FDA registration

ROCHE DIAGNOSTICS GMBH·1 product·🇩🇪 Germany

ZEUS SCIENTIFIC

FDA registration

ZEUS SCIENTIFIC·1 product·🇺🇸 United States

VITROS Anti-SARS-CoV-2 Total N Antibody Reagent Pack EUA210355

FDA registration

ORTHO-CLINICAL DIAGNOSTICS, INC.·1 product·🇺🇸 United States

RightSign COVID-19 IgG/IgM Rapid Test Cassette

FDA registration

Hangzhou Biotest Biotech Co.,Ltd.·1 product·🇨🇳 China

COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

FDA registration

MERCEDES MEDICAL LLC·1 product·🇺🇸 United States

COVID-19 IgM/IgG Rapid Test(Colloidal Gold)

FDA registration

JIANGSU WELL BIOTECH CO.,LTD.·1 product·🇨🇳 China

Anti-SARS-CoV-2 PC Elecsys

FDA registration

ROCHE DIAGNOSTICS INTERNATIONAL LTD.·1 product·🇨🇭 Switzerland

VITROS Anti-SARS-CoV-2 Total N Antibody Reagent Pack EUA210355

FDA registration

Ortho-Clinical Diagnostics·1 product·🇬🇧 United Kingdom

SARS-CoV-2-IgG Reagent Kit (ARCHITECT, LN 6R86-20, 6R86-30)

FDA registration

ABBOTT LABORATORIES·1 product·🇺🇸 United States

SARS-CoV-2 IgM & IgG Test System

FDA registration

TECO DIAGNOSTICS·1 product·🇺🇸 United States

COVID-19 IgG/IgM Rapid Test

FDA registration

Biomerica·1 product·🇺🇸 United States

Laboratorios Scantibodies, S.A. de C.V.

FDA registration

Laboratorios Scantibodies, S.A. de C.V.·1 product·🇲🇽 Mexico

SARS-CoV-2-IgG Reagent Kit (ARCHITECT, LN 6R86-20, 6R86-30)

FDA registration

ABBOTT IRELAND·1 product·🇮🇪 Ireland

HEALGEN SCIENTIFIC LLC

FDA registration

HEALGEN SCIENTIFIC LLC·1 product·🇺🇸 United States

Rapid Response COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)

FDA registration

BTNX Inc.·1 product·🇨🇦 Canada

Clarity COVIBLOCK COVID-19 IgG/IgM Antibody Test

FDA registration

SALOFA OY·1 product·🇫🇮 Finland

CHEMBIO DIAGNOSTIC SYSTEMS, INC.

FDA registration

CHEMBIO DIAGNOSTIC SYSTEMS, INC.·1 product·🇺🇸 United States

SARS-CoV-2 IgG assay (for use on ARCHITECT)

FDA registration

Fujirebio Diagnostics, Inc.·1 product·🇺🇸 United States