Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit

Device

EU IVDD · Eu Ivd General ·MedicalSystem Biotechnology Co., Ltd.·On the market

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

Device

EU IVDD · Eu Ivd General ·Nanjing Synthgene Medical Technology Co., Ltd. ·On the market

Access SARS-CoV-2 IgG (1st IS) (Reagent pack)

Device

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

4372DE410200424

Certificate

MDD Annex II (excluding section 4)·HELKUEB OHG·DNV MEDCERT GmbH·1 Basic UDI-DI

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

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC EIA

Herpes Simplex Virus Type 1/2 IgG Test Kit (FIA)

Device

EU IVDD · Eu Ivd General ·VivaChek Biotech (Hangzhou) Co., Ltd.·On the market

2-ME Roztwór do różnicowania przeciwciał klasy IgM i IgG

Device

EU IVDR · Eu Ivd Class A ·Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach·On the market

ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

2019-Novel Coronavirus(2019-nCoV) IgG/IgM GICA Rapid Test

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Monkeypox Virus（MPxV）IgM/IgG Rapid Detection Kit （Immunochromatography Assay）

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

RapidFor™ HSV (1/2) IgG/IgM Rapid Test Kit

Device

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·On the market

RapidFor™ Dengue IgG/IgM + NS1 Combo Rapid Test Kit

Device

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·On the market

ONE STEP Anti-Dengue (IgM & IgG) Tri-line Test

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·No longer on the market

GSP®/DELFIA® Anti-SARS-CoV-2 IgG kit

Device

EU IVDD · Eu Ivd General ·Wallac Oy·No longer on the market·32 countries

Mononucleosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

Device

EU IVDD · Eu Ivd General ·Zhejiang Orient Gene Biotech Co., Ltd·On the market

Anti-Dia, for card method Coombs-reactive, polyclonal, human IgG

Device

EU IVDR · Eu Ivd Class C ·ANTITOXIN GmbH·On the market·2 countries

Anti-Wra, for card method Coombs-reactive, polyclonal, human IgG

Device

EU IVDR · Eu Ivd Class C ·ANTITOXIN GmbH·On the market·2 countries

Anti-Cob, for card method Coombs-reactive, polyclonal, human IgG

Device

EU IVDR · Eu Ivd Class C ·ANTITOXIN GmbH·On the market·2 countries

Anti-Coa, for card method Coombs-reactive, polyclonal, human IgG

Device

EU IVDR · Eu Ivd Class C ·ANTITOXIN GmbH·On the market·2 countries