5,688 results
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42ms
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Sources: EU EUDAMED, US FDA
Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit
Device
EU IVDD
·
Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·On the market
Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent
Device
EU IVDR
·
Eu Ivd Class C
·Immucor, Inc.·On the market·32 countries
RapidFor™ Dengue IgG/IgM/NS1 Rapid Test Kit
Device
EU IVDD
·
Eu Ivd General
·Vitrosens Biyoteknoloji Anonim Şirketi·On the market
TOXO Toxoplasma Antibody IgG Rapid Test Kit (Colloidal Gold)
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Qingdao Hightop Biotech Co., Ltd.·On the market
Novel Coronavirus (COVID-19)IgG/IgM Rapid Test Device
Device
EU IVDD
·
Eu Ivd General
·Hangzhou Cybereagen Biotech Co., Ltd.·On the market
RapidFor™ Zika IgG/IgM Rapid Test Kit (FIA)
Device
EU IVDD
·
Eu Ivd General
·Vitrosens Biyoteknoloji Anonim Şirketi·On the market
RapidFor™ Dengue IgG/IgM Rapid Test Kit (FIA)
Device
EU IVDD
·
Eu Ivd General
·Vitrosens Biyoteknoloji Anonim Şirketi·On the market
RapidFor™ HSV-2 IgG/IgM Rapid Test Kit
Device
EU IVDD
·
Eu Ivd General
·Vitrosens Biyoteknoloji Anonim Şirketi·On the market
Herpes Simplex Virus HSV1/2 IgG/IgM Rapid Test
Device
EU IVDD
·
Eu Ivd General
·Hangzhou Immuno Biotech Co., Ltd·On the market
RapidFor™ HSV-1 IgG/IgM Rapid Test Kit
Device
EU IVDD
·
Eu Ivd General
·Vitrosens Biyoteknoloji Anonim Şirketi·On the market
SARS-CoV-2 IgG Antibody Test Kit (Fluorescence immunochromatography)
Device
EU IVDD
·
Eu Ivd General
·Kangmei Tianhong Biotech (Beijing) Co., Ltd.·On the market
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
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
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADAPTA, VERSA, SENSIA IPG. ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, ENOUKSE E2 IOG, KAPPA D IPG,KAPPA DR IP
HEp-2000® IgG Fluorescent ANA-Ro Test System
FDA UDI
IMMUNO CONCEPTS INC·M7492000CS21RO1·HEp-2000® IgG FA w/cs ANA-Ro Bulk Pack - 2100 T...
HEp-2000® IgG Fluorescent ANA-Ro Test System
FDA UDI
IMMUNO CONCEPTS INC·M7498264RO1·Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 630...
Anti-IgG,-C3d (Polyspecific) (Murine Monoclonal) (Green) Gamma-clone
FDA UDI
IMMUCOR, INC.·10888234001683·This product is used in direct or indirect anti...
HEp-2000® IgG Fluorescent ANA-Ro Test System
FDA UDI
IMMUNO CONCEPTS INC·M7498320RO1·Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 630...