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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
Fully Automated Nucleic Acid Extraction System AutoPrep96
Hybribio Medtech Device Co., Ltd
·
,
China
Class A
CE/IVDR
isoQuarkF2
RevoSketch Inc.
·
,
South Korea
Class A
CE/IVDR
TANBead Nucleic Acid Extractor
Taiwan Advanced Nanotech INC.
·
,
Taiwan
Class A
CE/IVDR
GUDID
on market
Fully Automated Sample Preparation Liquid Handling System
Hybribio Medtech Device Co., Ltd
·
,
China
Class A
CE/IVDR
Quantitative Real-time PCR System
Zybio Inc.
·
,
China
Class A
CE/IVDR
HighPrep PCR - DX (100 mL)
MagBio Genomics, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
Real-time PCR Detection System
Daan Gene Co., Ltd.
·
,
China
Class A
CE/IVDR
Galaxy Lite
Igenesis(Shanghai)Co., Ltd.
·
,
China
Class A
CE/IVDR
LineGene K Plus Fluorescent Quantitative Detection System
Hangzhou Bioer Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
LOAA-M Powerbox System
OPTOLANE Technologies Inc.
·
,
South Korea
Class A
CE/IVDR
DTprime II 5Х1
DNA-Technology, Research & Production, LLC
·
,
Russia
Class A
CE/IVDR
Real-time Quantitative Thermal Cycler
Suzhou Molarray Co., Ltd
·
,
China
Class A
CE/IVDR
TANBead Nucleic Acid Extractor
Taiwan Advanced Nanotech INC.
·
,
Taiwan
Class A
CE/IVDR
GUDID
on market
PGDx elio tissue complete
Personal Genome Diagnostics, Inc.
·
,
United States
Class C
FDA 510(k)
K192063
Active
Cleared 24 Apr 2020
CE/IVDR
Ultra Fast Real-time PCR System
Zybio Inc.
·
,
China
Class A
CE/IVDR
Real-time PCR system
Hangzhou Bio-gener Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Real-time PCR system
Hangzhou Bio-gener Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
DTprime II 4Х1
DNA-Technology, Research & Production, LLC
·
,
Russia
Class A
CE/IVDR
LineGene Mini Fluorescent Quantitative Detection System
Hangzhou Bioer Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Automatic Integrated Gene Detection System
Hangzhou Lifereal Biotechnology Co., Ltd
·
,
China
Class A
CE/IVDR
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