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In vitro diagnostic medical devices
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IVD instruments
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Nucleic acid testing instruments
Nucleic acid testing instruments
W0205
978 devices
Subcategories
3
W020501
Nucleic acid testing instruments except micro-arrays
866
devices
›
W020502
Micro-array instruments
28
devices
›
W020503
Nucleic acid testing instruments - rapid and point of care tests
84
devices
›
Devices
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
DTprime II 4М6
DNA-Technology, Research & Production, LLC
·
,
Russia
Class A
CE/IVDR
DTstream 9М1
DNA-Technology, Research & Production, LLC
·
,
Russia
Class A
CE/IVDR
Real-time Quantitative Thermal Cycler
Jiangsu Q-Array Co., Ltd.
·
,
China
Class A
CE/IVDR
DTprime II 4M1
DNA-Technology, Research & Production, LLC
·
,
Russia
Class A
CE/IVDR
DTprime II 6М1
DNA-Technology, Research & Production, LLC
·
,
Russia
Class A
CE/IVDR
Sa2Res
Sacace Biotechnologies S.r.l
·
,
Italy
Class A
CE/IVDR
Hand-held Nucleic Acid Detection Analyzer
Zhuhai Shineway Biotech Co., Ltd
·
,
China
Class A
CE/IVDR
GUDID
on market
CentriDx Automated Nucleic Acid Analyzer
Hangzhou Bioer Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
TANBead Nucleic Acid Extractor
Taiwan Advanced Nanotech INC.
·
,
Taiwan
Class A
CE/IVDR
GUDID
on market
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