19 results
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8ms
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Sources: EU EUDAMED, US FDA
AFP Control
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·On the market
CLIA AFP Control
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·On the market
CLIA AFP Calibrator
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·On the market
AFP CLIA Microparticles
Device
EU IVDR
·
Eu Ivd Class C
·Autobio Diagnostics Co., Ltd.·On the market·3 countries
AFP CLIA Microparticles
Device
EU IVDR
·
Eu Ivd Class C
·Autobio Diagnostics Co., Ltd.·On the market·3 countries
AFP Assay kit CLIA
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·On the market
AFP Assay kit CLIA
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·On the market
Merlin Biomedical (Xiamen) Co., Ltd.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·CeCert Sp. z o.o.
AFP Control
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
Diagnostic Kit for Alpha-fetoprotein (AFP) (Time-resolved Fluorescence Immunochromatographic Assay)
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·On the market
AFP Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
CLIA AFP Control
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
CLIA AFP Calibrator
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
AFP Assay kit CLIA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
AFP Assay kit CLIA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
SARS-CoV-2 Antigen Rapid Test Cassette
Device
EU IVDD
·
Eu Ivd Self Testing
·Merlin Biomedical (Xiamen) Co., Ltd.·On the market
Diagnostic Kit for Alpha-fetoprotein (AFP) (Time-resolved Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
SARS-CoV-2 Antigen Rapid Test Cassette
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Merlin Biomedical (Xiamen) Co., Ltd.·1 device
CeCert/037/W/E.1
Certificate
IVDD Annex III Section 6·Merlin Biomedical (Xiamen) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI