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

Basic UDI-DI

EU IVDD · Eu Ivd General ·Hangzhou Immuno Biotech Co., Ltd·1 device

COVID-19 Ag and IgG/IgM Ab(High Sensitivity) Combo Rapid Test

Basic UDI-DI

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

ONE STEP Anti-Dengue IgG/IgM Tri-line Rapid Test (Colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

ONE STEP Anti-Dengue IgG/IgM Tri-line Rapid Test (Colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

Labmaster LUCIA™ SARS-CoV-2 IgG NP Kit For Serum/Plasma Samples

Basic UDI-DI

EU IVDD · Eu Ivd General ·Labmaster Oy·1 device

Labmaster LUCIA™ SARS-CoV-2 IgG RBD Kit for Whole Blood Samples

Basic UDI-DI

EU IVDD · Eu Ivd General ·Labmaster Oy·1 device

Labmaster LUCIA™ SARS-CoV-2 IgG NP Kit for Whole Blood Samples

Basic UDI-DI

EU IVDD · Eu Ivd General ·Labmaster Oy·1 device

Eurolink Europe Compliance Limited

Authorized representative

🇮🇪 Ireland·35 Manufacturers·252 Devices

Anti-D IgG/IgM Blend Reagent (Titer: 1/64), 10ml/vial, 1Vial/carton Box

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·Atlas Medical GmbH·1 device

Anti-CDE monoclonal, human IgM + IgG clones: MS-24, MS-201, MS-80, MS-26

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·ANTITOXIN GmbH·1 device

Anti-D IgG/IgM Blend Reagent (Titer: 1/64), 10ml/vial, 10 vials/Plastic Pack

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·Atlas Medical GmbH·1 device

Anti-D IgG/IgM Blend Reagent (Titer: 1/128), 10ml/vial, 10 vials/Plastic Pack

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·Atlas Medical GmbH·1 device

Anti-D IgG/IgM Blend Reagent (Titer: 1/128), 10ml/vial, 1 vial/carton Box

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·Atlas Medical GmbH·1 device

Detection Kit for Severe Fever with Thrombocytopenia Syndrome Virus IgM/IgG Antibody  (Colloidal Gold Method)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zhongshan Bio-Tech Co., Ltd.·1 device

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR

Assisted Reproduction Laminar Flow Workstation

FDA classification

FDA Class 2 ·Assisted Reproduction Laminar Flow Workstation

Accessory, Assisted Reproduction, Exempt

FDA classification

FDA Class 2 ·Accessory, Assisted Reproduction, Exempt

Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

FDA classification

FDA Class 2 ·Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

FDA classification

FDA Class 2 ·Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

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