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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
MagFast 16 Genomic DNA Purification Kit from Bacteria
Vitrosens Biotechnology Inc.
·
,
Türkiye
Class A
CE/IVDR
PsorX-LabDisk
Dermagnostix GmbH
·
,
Germany
IVD General
CE/IVDD
MiniDock Ultra
Guangzhou Pluslife Biotech Co., Ltd
·
,
China
Class A
CE/IVDR
Quantitative Real-time PCR System
Zybio Inc.
·
,
China
Class A
CE/IVDR
GeneXpert®
Cepheid
·
,
United States
Class A
CE/IVDR
GUDID
on market
MagFast Total Nucleic Acid Purification Kit
Vitrosens Biotechnology Inc.
·
,
Türkiye
Class A
CE/IVDR
MagFast 16 Genomic DNA Purification Kit From Blood
Vitrosens Biotechnology Inc.
·
,
Türkiye
Class A
CE/IVDR
GeneXpert
Cepheid
·
,
United States
Class A
CE/IVDR
GUDID
on market
LOAA-M Module
OPTOLANE Technologies Inc.
·
,
South Korea
Class A
CE/IVDR
DTprime II 6М6
DNA-Technology, Research & Production, LLC
·
,
Russia
Class A
CE/IVDR
Automatic Nucleic Acid Extraction and Real-Time PCR System
GuangDong Brightbiomed Co., Ltd.
·
,
China
Class A
CE/IVDR
Real-time Quantitative Thermal Cycler
Jiangsu Q-Array Co., Ltd.
·
,
China
Class A
CE/IVDR
GenePure 96 Nucleic Acid Purification System
Hangzhou Bioer Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
careSTART™ Q1 Amplifier
Hangzhou Bioer Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
GUDID
on market
Microfluidic Nucleic Acid Analyzer
R&G Biotech Co., Ltd
·
,
China
Class A
CE/IVDR
QIAcuityDx Four
QIAGEN GmbH
·
,
Germany
Class A
CE/IVDR
GUDID
on market
HG-N32 Nucleic Acid Purification System
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
MagFast 16-Flex Total Nucleic Acid Purification Kit
Vitrosens Biotechnology Inc.
·
,
Türkiye
Class A
CE/IVDR
NEOS-96 XT Nucleic Acid Extractor System
Linear Chemicals S.L.U
·
,
Spain
Class A
CE/IVDR
Real-Time PCR System
Aperbio Technologies (Suzhou) Co., Ltd
·
,
China
Class A
CE/IVDR
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