43 results
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18ms
·
Sources: EU EUDAMED, US FDA
Napsin A (QR058)
Device
EU IVDD
·
Eu Ivd General
·biocyc Biotechnologie GmbH & Co. KG·On the market
CoxA16 & EV71 Real Time PCR Kit
Device
EU IVDD
·
Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·On the market·32 countries
Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)
Device
EU IVDD
·
Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market
Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)
Device
EU IVDD
·
Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market
Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)
Device
EU IVDD
·
Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market
Monkeypox Virus Antigen Detection Kit (Immunochromatography)
Device
EU IVDD
·
Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market
Monkeypox Virus Antigen Detection Kit (Immunochromatography)
Device
EU IVDD
·
Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market
Cervical Pre-cancer And Cancer Rapid Test Kit (Colloidal gold method)
Device
EU IVDD
·
Eu Ivd General
·Nanjing Synthgene Medical Technology Co., Ltd. ·On the market
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
Device
EU IVDD
·
Eu Ivd General
·Gold Probe Diagnostic Biotechnology Inc. MF·On the market
BioCLIA Autoimmune Reagent Kit, Nucleosome
Device
EU IVDD
·
Eu Ivd General
·HOB Biotech Group Corp., Ltd.·On the market
Human NTRK Genes Fusion Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
Device
EU IVDD
·
Eu Ivd General
·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries
Human BCR-ABL Gene T315I Mutation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
Device
EU IVDD
·
Eu Ivd General
·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries
ALK/ROS1/RET Gene Fusion Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
Device
EU IVDD
·
Eu Ivd General
·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries
EGFR Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
Device
EU IVDD
·
Eu Ivd General
·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries
MLH1 Gene Methlyation Detection Kit Multiplex Fluorescence Polymerase Chain Reaction
Device
EU IVDD
·
Eu Ivd General
·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries
EGFR Gene T790M Mutation Detection Kit (Digital PCR)
Device
EU IVDD
·
Eu Ivd General
·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries
K-ras Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
Device
EU IVDD
·
Eu Ivd General
·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries
Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing)
Device
EU IVDD
·
Eu Ivd General
·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries
Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing)
Device
EU IVDD
·
Eu Ivd General
·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries
Thyroid Cancer Gene Mutation Detection Kit (High Throughput Sequencing)
Device
EU IVDD
·
Eu Ivd General
·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries