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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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DNA genomic preparation devices
DNA genomic preparation devices
W02050106
100 devices
MagCore® EDA Automated Nucleic Acid Extractor and Assay Setup
RBCBioscience Corp.
·
,
Taiwan
Class A
CE/IVDR
PowerEXP™ 48LH
KogeneBiotech Co., Ltd.
·
,
South Korea
Class A
CE/IVDR
Automatic Nucleic Acid Extractor
Xi'an Tianlong Science and Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
qMate Mini Nucleic Acid Extraction System
Aperbio Technologies (Suzhou) Co., Ltd
·
,
China
Class A
CE/IVDR
Automatic Nucleic Acid Extractor
Xi'an Tianlong Science and Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Automated Workstation
Suzhou Sym-Bio Lifescience Co., Ltd.
·
,
China
Class A
CE/IVDR
MagCore® Compact Automated Nucleic Acid Extractor
RBCBioscience Corp.
·
,
Taiwan
Class A
CE/IVDR
Pre-NAT II (SY61-EI)
Suzhou Sym-Bio Lifescience Co., Ltd.
·
,
China
Class A
CE/IVDR
Real-time PCR System
Xi'an Tianlong Science and Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
pureNA® Genomic DNA Isolation Kit
EntroGen, Inc.
·
,
United States
Class A
CE/IVDR
MT-Prep 24 System
AusDiagnostics Pty Ltd
·
,
Australia
Class A
CE/IVDR
Revogene® Mock Pie
Meridian Bioscience, Inc.
·
,
United States
Class A
FDA 510(k)
×3
K220480
Active
Cleared 11 Jul 2022
CE/IVDR
+1
authorizations
Automated Workstation
Suzhou Sym-Bio Lifescience Co., Ltd.
·
,
China
Class A
CE/IVDR
Real-time PCR System
Xi'an Tianlong Science and Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Nucleic Acid Purification System
Hangzhou Bio-gener Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Real-time PCR System
Xi'an Tianlong Science and Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
MagnisDx NGS Prep System
Agilent Technologies Singapore (International) Pte Ltd
·
,
Singapore
Class A
CE/IVDR
QIAcube Connect MDx
QIAGEN GmbH
·
,
Germany
Class A
CE/IVDR
GUDID
on market
Automatic Nucleic Acid Extractor
RocGene (Xuzhou) Technology Limited
·
,
China
Class A
CE/IVDR
MagCore® HF16 Plus Automated Nucleic Acid Extractor
RBCBioscience Corp.
·
,
Taiwan
Class A
CE/IVDR
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