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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
Real-time PCR system
Hangzhou Bio-gener Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Ion OneTouch™ ES Dx Instrument
Life Technologies Holdings Pte Ltd.
·
,
Singapore
Class A
CE/IVDR
GUDID
on market
NEOS-48 qPCR Real-Time PCR System
Linear Chemicals S.L.U
·
,
Spain
Class A
CE/IVDR
Real-Time Fluorescence Quantitative PCR System
Nanjing Vazyme Medical Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
NEOS-96 qPCR Real-Time PCR System. 4 Channels
Linear Chemicals S.L.U
·
,
Spain
Class A
CE/IVDR
SAMBA III Tablet Module
Diagnostics for the Real World (Europe) Ltd.
·
,
United Kingdom
Class A
CE/IVDR
Pluslife Dock Pro 8
Guangzhou Pluslife Biotech Co., Ltd
·
,
China
Class A
CE/IVDR
DTstream 9L4
DNA-Technology, Research & Production, LLC
·
,
Russia
Class A
CE/IVDR
MagFast 16-Flex Genomic DNA Purification Kit From Blood
Vitrosens Biotechnology Inc.
·
,
Türkiye
Class A
CE/IVDR
Real-time PCR
Infitek Co., Ltd.
·
,
China
Class A
CE/IVDR
Rapid Detection System
Daan Gene Co., Ltd.
·
,
China
Class A
CE/IVDR
bCUBE3
Hyris SRL
·
,
Italy
Class A
CE/IVDR
LineGene MiniS Fluorescent Quantitative Detection System
Hangzhou Bioer Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
GUDID
on market
1499100100
Genesystem Co., Ltd.
·
,
South Korea
Class A
CE/IVDR
Quantitative Real-time PCR System
Zybio Inc.
·
,
China
Class A
CE/IVDR
Real-time qPCR System
Hangzhou LongGene Scientific Instruments Co., Ltd.
·
,
China
Class A
CE/IVDR
Full-Automatic Nucleic Acid Extraction and qPCR Analysis System
Suzhou Molarray Co., Ltd
·
,
China
Class A
CE/IVDR
MagFast 16 Total Nucleic Acid Purification Kit
Vitrosens Biotechnology Inc.
·
,
Türkiye
Class A
CE/IVDR
Automatic Nucleic Acid Extraction and Real-Time PCR System
Beijing Applied Biological Technologies Co., Ltd.
·
,
China
Class A
CE/IVDR
Hand-held Nucleic Acid Detection Analyzer
Zhuhai Shineway Biotech Co., Ltd
·
,
China
Class A
CE/IVDR
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