RapidFor™ SARS-CoV-2 IgG/IgM Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device

2O19-nCoV IgG/IgM Rapid Test Device(colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd General ·hangzhou lysun biotechnology co.,ltd·1 device

2O19-nCoV IgG/IgM Rapid Test Device(colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd General ·hangzhou lysun biotechnology co.,ltd·1 device

Detection Kit for Hepatitis E Virus IgM Antibody (ELISA)

Basic UDI-DI

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

Typhoid IgG/IgM Rapid Test Kit (Colloidal gold method)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Nanjing Synthgene Medical Technology Co., Ltd. ·1 device

Dengue IgG & IgM Antibody Kit (Microfluidic Fluorescent Immunoassay)

Basic UDI-DI

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

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

Basic UDI-DI

EU IVDD · Eu Ivd General ·JOYSBIO(Tianjin) Biotechnology Co., Ltd.·1 device

10000328121-PA-NA-TWN

Certificate

MDD Annex II (excluding section 4)·Geon Corporation·DNV Product Assurance AS·10 Basic UDI-DIs

10075-2017-CE-IND-NA-PS

Certificate

MDD Annex II (excluding section 4)·STERICON PHARMA PVT.LTD·DNV Product Assurance AS·4 Basic UDI-DIs

Babesia Spp. Serological Reagents

FDA classification

FDA Not Classified ·Babesia Spp. Serological Reagents

Bartonella Spp. Serological Reagents

FDA classification

FDA Not Classified ·Bartonella Spp. Serological Reagents

Orientia Spp. (Scrub Typhus) Serological Reagents

FDA classification

FDA Not Classified ·Orientia Spp. (Scrub Typhus) Serological Reagents

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA classification

FDA Class 3 ·Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

Igm (Mu Chain Specific), Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Igm (Mu Chain Specific), Antigen, Antiserum, Control

Hepatitis A Test (Antibody And Igm Antibody)

FDA classification

FDA Class 2 ·Hepatitis A Test (Antibody And Igm Antibody)

Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Ningbo BESTest Bio-technology Co.,Ltd.·1 device

Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Ningbo BESTest Bio-technology Co.,Ltd.·1 device

RV Rubella Antibodies IgM/IgG Rapid Test Kit(Colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Qingdao Hightop Biotech Co., Ltd.·1 device

TOXO Toxoplasma Antibody IgM/ IgG Rapid Test Kit (Colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Qingdao Hightop Biotech Co., Ltd.·1 device

Anti-s, for card method monoclonal, human IgM clone: P3BER

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·ANTITOXIN GmbH·1 device