664 results · 7ms · Sources: EU EUDAMED, US FDA

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Hemoglobin Testing System

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·VivaChek Biotech (Hangzhou) Co., Ltd.·1 device

Chitinase-3-like protein 1 (kit) (Colloidal Gold)

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EU IVDR · Eu Ivd Class A ·Hangzhou Proprium Biotech Co.Ltd·1 device

Rapid SARS-CoV-2 Antigen Test Card

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EU IVDD · Eu Ivd Self Testing ·Xiamen Boson Biotech Co., Ltd.·1 device

Rapid SARS-CoV-2 Antigen Test Card

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EU IVDD · Eu Ivd Self Testing ·Xiamen Boson Biotech Co., Ltd.·1 device

Rapid SARS-CoV-2 Antigen Test Card

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EU IVDD · Eu Ivd General ·Xiamen Boson Biotech Co., Ltd.·1 device

Rapid SARS-CoV-2 Antigen Test Card

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Xiamen Boson Biotech Co., Ltd.·1 device

Rapid SARS-CoV-2 Antigen Test Card

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Xiamen Boson Biotech Co., Ltd.·1 device

Neisseria Gonorrhoeae/Chlamydia Trachomatis/U. Urealyticum Real Time PCR Kit

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EU IVDD · Eu Ivd General ·Gold Probe Diagnostic Biotechnology Inc. MF·1 device

Lung Cancer Mutant Genes Detction Panel (Multiplex Real-time PCR)

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EU IVDD · Eu Ivd General ·Gold Probe Diagnostic Biotechnology Inc. MF·1 device

TERT Promoter Mutation Detection Kit(Real-time PCR Assays)

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EU IVDD · Eu Ivd General ·Gold Probe Diagnostic Biotechnology Inc. MF·1 device

KRAS/NRAS/PIK3CA/BRAF Mutations Detection Kit (Real-time PCR Assays)

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EU IVDD · Eu Ivd General ·Gold Probe Diagnostic Biotechnology Inc. MF·1 device

IDH1/IDH2 Gene Mutation Detection Kit

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EU IVDD · Eu Ivd General ·Gold Probe Diagnostic Biotechnology Inc. MF·1 device

Human Papillomavirus Detection Kit (Multiplex Real-time PCR)

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EU IVDD · Eu Ivd General ·Gold Probe Diagnostic Biotechnology Inc. MF·1 device

Sample Extraction Solution

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EU IVDD · Eu Ivd General ·Gold Probe Diagnostic Biotechnology Inc. MF·1 device

Nucleic Acid Extraction Kit

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EU IVDD · Eu Ivd General ·Gold Probe Diagnostic Biotechnology Inc. MF·1 device

HER-2 DNA Probe Kit

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EU IVDD · Eu Ivd General ·Gold Probe Diagnostic Biotechnology Inc. MF·1 device

Real time RT-PCR Kit for SARS-2 Flu A Flu B

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EU IVDD · Eu Ivd General ·Gold Probe Diagnostic Biotechnology Inc. MF·1 device

Real-Time PCR Kit for Detection of SARS-CoV-2

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EU IVDD · Eu Ivd General ·Gold Probe Diagnostic Biotechnology Inc. MF·1 device

COVID-19 Neutralization Antibody IFU version 2021-01

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EU IVDD · Eu Ivd General ·Gold Probe Diagnostic Biotechnology Inc. MF·1 device

COVID-19 Antigen IFU version 2022-01

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EU IVDD · Eu Ivd General ·Gold Probe Diagnostic Biotechnology Inc. MF·1 device