SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shanghai GeneoDx Biotech Co., Ltd.·1 device

COVID-19 (SARS-CoV-2) Antigen Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.·1 device

COVID-19 (SARS-CoV-2) Antigen Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.·1 device

COVID-19 (SARS-CoV-2) Antigen Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.·1 device

SARS-CoV-2 Neutralization Antibody Rapid Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Jiangsu Mole Bioscience Co., LTD.·1 device

SARS-CoV-2 Total Antibody Rapid Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Jiangsu Mole Bioscience Co., LTD.·1 device

SARS-CoV-2 Neutralization Antibody Test Kit (ELISA)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Jiangsu Mole Bioscience Co., LTD.·1 device

SARS-CoV-2 Total Antibody Test Kit (ELISA)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Jiangsu Mole Bioscience Co., LTD.·1 device

First Sign® SARS-CoV-2 Antigen Test

Basic UDI-DI

EU IVDD · Eu Ivd General ·W.H.P.M. Bioresearch & Technology Co., Ltd.·1 device

cPass SARS-CoV-2 Neutralization Antibody Detection Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Nanjing Genscript Diagnostics Technology Co., Ltd.·1 device

Access SARS-CoV-2 IgG II (reagent pack)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

RealAccurate® Quadruplex SARS-CoV-2 PCR Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·PathoFinder B.V.·1 device

SARS-CoV-2 Real time Fluorescent PCR Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

SARS-CoV-2 Real time Fluorescent PCR Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

i-STAT PT/INR Cartridge

FDA registration

ABBOTT POINT OF CARE CANADA LIMITED·16 products·🇨🇦 Canada

Chemistry

FDA registration

Diamond Diagnostics Inc.·16 products·🇭🇺 Hungary

BIOFIRE SPOTFIRE Module

FDA registration

BioFire Diagnostics, LLC·10 products·🇺🇸 United States

i-STAT PT/INR Cartridge

FDA registration

ABBOTT POINT OF CARE INC.·16 products·🇺🇸 United States

LIAISON PLEX Respiratory Flex Assay

FDA registration

Luminex Corporation·10 products·🇺🇸 United States

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification

FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents