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In vitro diagnostic medical devices
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IVD instruments
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Nucleic acid testing instruments
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Nucleic acid testing instruments except micro-arrays
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Nucleic acid testing integrated extraction /amplification /detection systems
Nucleic acid testing integrated extraction /amplification /detection systems
W02050116
424 devices
DTstream 12L4
DNA-Technology, Research & Production, LLC
·
,
Russia
Class A
CE/IVDR
GeneExplorer Thermal Cycler
Hangzhou Bioer Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
GUDID
on market
Real-time PCR Nucleic Acid Detection System
Zhuhai Shineway Biotech Co., Ltd
·
,
China
Class A
CE/IVDR
Fluorescent Quantitative Detection System
Shandong Bohong Gene Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
GeneExplorer Thermal Cycler
Hangzhou Bioer Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
NeXgen 16HP
Zinexts Life Science Corp.
·
,
Taiwan
Class A
CE/IVDR
Biocomma
Biocomma Limited
·
,
China
Class A
CE/IVDR
Real-time PCR Quantitative Analyzer
Singuway Biotech Inc.
·
,
China
Class A
CE/IVDR
Nucleic Acid Analysis Device
Sansure Biotech Inc.
·
,
China
Class A
CE/IVDR
MiniLab System
Delbio Inc.
·
,
Taiwan
Class A
CE/IVDR
IRON-qPCR™
Bioneer Corporation
·
,
South Korea
Class A
CE/IVDR
PGDx elio tissue complete
Personal Genome Diagnostics, Inc.
·
,
United States
Class C
CE/IVDR
SGPrep32
HANWOOLTPC Co., Ltd.
·
,
South Korea
Class A
CE/IVDR
Real-time PCR system
Hangzhou Bio-gener Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
QIAstat-Dx Operational Module
QIAGEN GmbH
·
,
Germany
Class A
CE/IVDR
GUDID
on market
QIAsymphony AS
QIAGEN GmbH
·
,
Germany
Class A
CE/IVDR
GUDID
on market
geneLEAD XXIV
Precision System Science Co., Ltd.
·
,
Japan
Class A
CE/IVDR
BaseTyper
PentaBase A/S
·
,
Denmark
Class A
CE/IVDR
All-in-one Molecular Diagnosis System
Xi'an Tianlong Science and Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
3500xL Dx Genetic Analyzer
Life Technologies Holdings Pte Ltd.
·
,
Singapore
Class A
CE/IVDR
GUDID
on market
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