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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
Vanadis Extract
Wallac Oy
·
,
Finland
Class A
CE/IVDR
Automatic Nucleic Acid Detection Analyzer
Guangdong RunPon Bioscience Inc.
·
,
China
Class A
CE/IVDR
GeneXpert®
Cepheid
·
,
United States
Class A
CE/IVDR
GUDID
on market
GeneXpert®
Cepheid
·
,
United States
Class A
CE/IVDR
GUDID
on market
Automatic Nucleic Acid Detection and Analysis System
Shanghai Rendu Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
Real-time PCR system
Hangzhou Bio-gener Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Biocomma
Biocomma Limited
·
,
China
Class A
CE/IVDR
Automatic Nucleic Acid Extraction System
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
Class A
CE/IVDR
GUDID
on market
Real-time fluorescence quantitative PCR analyzer
Chongqing ME Instruments Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Nucleic Acid Extractor
Shandong Bohong Gene Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Uni-medica
Shenzhen Uni-medica Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
cobas® eplex system
GenMark Diagnostics
·
,
United States
Class A
CE/IVDR
MagFast Single-Cartridge Genomic DNA Purification Kit From Blood
Vitrosens Biotechnology Inc.
·
,
Türkiye
Class A
CE/IVDR
STANDARD™ M10 Module
Sd Biosensor, Inc.
·
,
South Korea
Class A
CE/IVDR
HighPrep PCR - DX (500 mL)
MagBio Genomics, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
Sanity 2.0 System
Xiamen Zeesan Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Automated Nucleic Acid Purification and Real Time PCR System
Hangzhou Bioer Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Automated TRCR Real-time Monitor TRCReady-80
Tosoh Corporation
·
,
Japan
Class A
CE/IVDR
Automated Nucleic Acid Purification and Real Time PCR System
Hangzhou Bioer Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
QuantStudio™ 7 Pro Dx Real‑Time PCR Instrument
Life Technologies Holdings Pte Ltd.
·
,
Singapore
Class A
CE/IVDR
GUDID
on market
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