Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Abbott RealTime IDH2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

COVID-19 MPX 1-Step NGene PCR-L CE-IVD. Placa 96 Reacciones.

Device

EU IVDD · Eu Ivd General ·SISTEMAS GENOMICOS. S.L.·On the market

COVID-19 MPX 1-Step N Gene PCR. CE-IVD. Tubo 96 Reacciones

Device

EU IVDD · Eu Ivd General ·SISTEMAS GENOMICOS. S.L.·On the market

Pneumocystis Jiroveci, Cryptococcus Neoformans and Aspergillus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Device

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

Adenovirus and Adenovirus 3/7 Subtypes Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Device

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Device

EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market

14 Kinds of Genitourinary Tract Infection Pathogen Nucleic Acid Detection Kit (Fluorescence PCR)

Device

EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market

Dengue Fever Virus Genotyping Ⅰ/Ⅱ/Ⅲ/Ⅳ Real Time RT-PCR Kit

Device

EU IVDD · Eu Ivd General ·SHANGHAI ZJ BIO-TECH CO., LTD·On the market

Twenty Bloodstream Pathogenic Microorganisms and Drug Resistance Genes Detection Kit (Digital PCR Method）

Device

EU IVDR · Eu Ivd Class A ·Pilot Gene Technology (Hangzhou) Co., Ltd·On the market

Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens

Device

EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market

Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens

Device

EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market

Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens

Device

EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market

Adenovirus and Adenovirus 3/7 Subtypes Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Device

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

Human papillomavirus (Type 16 and 18) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Device

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

Human papillomavirus (Type 6 and 11) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Device

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)

Device

EU IVDD · Eu Ivd General ·Jiangsu Mole Bioscience Co., LTD.·On the market

Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2

Device

EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market

Human Papillomavirus Nucleic Acid Detection and HPV16/18 Genotyping Kit (PCR-Fluorescence Probing)

Device

EU IVDD · Eu Ivd General ·Yaneng BIOscience (Shenzhen) Co., Ltd.·On the market·1 country

Human Papillomavirus Nucleic Acid Detection and HPV16/18 Genotyping Kit (PCR-Fluorescence Probing)

Device

EU IVDD · Eu Ivd General ·Yaneng BIOscience (Shenzhen) Co., Ltd.·On the market·1 country