44 results
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10ms
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Sources: EU EUDAMED, US FDA
Covid-19 Antigen CARD Kit
Device
EU IVDD
·
Eu Ivd Self Testing
·Fosun Diagnostics (Shanghai) Co., Ltd.·On the market
Covid-19 Antigen CARD Kit
Device
EU IVDD
·
Eu Ivd Self Testing
·Fosun Diagnostics (Shanghai) Co., Ltd.·On the market
Covid-19 Antigen CARD Kit
Device
EU IVDD
·
Eu Ivd Self Testing
·Fosun Diagnostics (Shanghai) Co., Ltd.·On the market
Autoantibody against Thyroid peroxidase Assay Kit (Chemiluminescent Immunoassay)
Device
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·On the market
Blood Glucose Monitoring System
Device
EU IVDD
·
Eu Ivd Self Testing
·Beijing Lepu Medical Technology Co., Ltd.·On the market
SARS-COV-2 Antigen Rapid Tests for Self-Testing
Device
EU IVDD
·
Eu Ivd Self Testing
·Beijing Lepu Medical Technology Co., Ltd.·On the market
Blood Glucose, Ketone and Uric Acid Meters
Device
EU IVDD
·
Eu Ivd Self Testing
·Beijing Lepu Medical Technology Co., Ltd.·On the market
Uric Acid Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·Beijing Lepu Medical Technology Co., Ltd.·On the market
Ketone Test Strips
Device
EU IVDD
·
Eu Ivd Self Testing
·Beijing Lepu Medical Technology Co., Ltd.·On the market
Blood Glucose Test Strips
Device
EU IVDD
·
Eu Ivd Self Testing
·Beijing Lepu 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