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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
Devices
Applied Biosystems™ SeqStudio™ 24 Flex Dx Genetic Analyzer
Life Technologies Holdings Pte Ltd.
·
,
SG
Class A
CE/IVDR
TANBead Nucleic Acid Extractor
Taiwan Advanced Nanotech INC.
·
,
TW
Class A
CE/IVDR
NC-15Plus(32)
HANWOOLTPC Co., Ltd.
·
,
KR
Class A
CE/IVDR
GUDID
on market
3500 Dx Genetic Analyzer
Life Technologies Holdings Pte Ltd.
·
,
SG
Class A
CE/IVDR
GUDID
on market
isoQuarkM4
RevoSketch Inc.
·
,
KR
Class A
CE/IVDR
Automated Nucleic Acid Extraction and Amplification System
Hybribio Medtech Device Co., Ltd
·
,
CN
Class A
CE/IVDR
Real-time PCR system
Hangzhou Bio-gener Technology Co., Ltd.
·
,
CN
Class A
CE/IVDR
DTstream 15М4
DNA-Technology, Research & Production, LLC
·
,
RU
Class A
CE/IVDR
Real-time Quantitative Thermal Cycler
Suzhou Molarray Co., Ltd
·
,
CN
Class A
CE/IVDR
Portable Nucleic Acid Detection Instrument
Suzhou Molarray Co., Ltd
·
,
CN
Class A
CE/IVDR
Real-time Quantitative Thermal Cycler
Suzhou Molarray Co., Ltd
·
,
CN
Class A
CE/IVDR
Cleo™ One
Wizbiosolutions Inc.
·
,
KR
Class A
CE/IVDR
Real-time PCR system
Hangzhou Bio-gener Technology Co., Ltd.
·
,
CN
Class A
CE/IVDR
MagFast 16-Flex Genomic DNA Purification Kit From Bacteria
Vitrosens Biotechnology Inc.
·
,
TR
Class A
CE/IVDR
Biocomma
Biocomma Limited
·
,
CN
Class A
CE/IVDR
DTstream 15М1
DNA-Technology, Research & Production, LLC
·
,
RU
Class A
CE/IVDR
Nucleic Acid Extraction System
Xiamen Zeesan Biotech Co., Ltd.
·
,
CN
Class A
CE/IVDR
Real-time PCR system
Hangzhou Bio-gener Technology Co., Ltd.
·
,
CN
Class A
CE/IVDR
FlashDetect
Coyote Bioscience Co., Ltd.
·
,
CN
Class A
CE/IVDR
Real-time PCR Quantitative Analyzer
Singuway Biotech Inc.
·
,
CN
Class A
CE/IVDR
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