Cancer Predisposition Risk Assessment System

FDA classification

FDA Class 2 ·Cancer Predisposition Risk Assessment System

Whole Exome Sequencing Constituent Device

FDA classification

FDA Class 2 ·Whole Exome Sequencing Constituent Device

Hiv-1 Genotyping Assay Using Ngs Technology

FDA classification

FDA Class 2 ·Hiv-1 Genotyping Assay Using Ngs Technology

Direct-To-Consumer Access Pharmacogenetic Assessment System

FDA classification

FDA Class 2 ·Direct-To-Consumer Access Pharmacogenetic Assessment System

Bcr/Abl1 Monitoring Test

FDA classification

FDA Class 2 ·Bcr/Abl1 Monitoring Test

Jak2 Gene Mutation Detection Test

FDA classification

FDA Class 2 ·Jak2 Gene Mutation Detection Test

Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method

Basic UDI-DI

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

Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method

Basic UDI-DI

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

Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method

Basic UDI-DI

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

442765 Albumin Reagent (ALB 2 x 300)

FDA registration

BECKMAN COULTER, INC.·63 products·🇺🇸 United States

442765 Albumin Reagent (ALB 2 x 300)

FDA registration

BECKMAN COULTER, INC.·63 products·🇺🇸 United States

cobas 8000 cobas ISE MODULE [DOUBLE]

FDA registration

ROCHE DIAGNOSTICS GMBH·78 products·🇩🇪 Germany

cobas 8000 cobas ISE MODULE [DOUBLE]

FDA registration

ROCHE DIAGNOSTICS GMBH·78 products·🇩🇪 Germany

Analyzer

FDA registration

Diamond Diagnostics Inc.·78 products·🇭🇺 Hungary

cobas 8000 cobas ISE MODULE [DOUBLE]

FDA registration

ROCHE DIAGNOSTICS INTERNATIONAL LTD.·78 products·🇨🇭 Switzerland

Wellkang Ltd

Authorized representative

259 Manufacturers·3500 Devices

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 Devices