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In vitro diagnostic medical devices
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Genetic testing
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Genetic tests - other
Genetic tests - other
W010699
865 devices
Universal Sequencing Reaction Kit G400 SM App-A DB FCS PE150
Wuhan MGI Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
Universal Sequencing Reaction Kit (Package I) E25 SM FCL PE150
Qingdao MGI Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
Geneseeq multi-cancer early detection kit
Geneseeq Medical Device and Diagnostic Inc.
·
,
China
IVD General
CE/IVDD
GeneMind
GeneMind Biosciences Co., Ltd.
·
,
China
Class A
CE/IVDR
DNA Methylation-Lightning MagPrep
Beijing OriginPoly Bio-Tec Co., Ltd.
·
,
China
Class A
CE/IVDR
Universal Reaction Kit for Sequencing（Reversible Terminator Sequencing）
GeneMind Biosciences Co., Ltd.
·
,
China
Class A
CE/IVDR
Vazyme Target Capture Hybridization and Wash Kit
Nanjing Vazyme Medical Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Human Papillomavirus (HPV) Genotyping Detection Kit (Microarray)
CapitalBio Technology (Chengdu) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Universal Sequencing Reaction Kit T7 App-D FCL PE150
Wuhan MGI Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
DENV, ZIKV & YFV RT-PCR Assay
Shanghai Zymetas Medtech Co., Ltd
·
,
China
IVD General
CE/IVDD
ALDH2 Genotyping Kit (PCR Capillary Electrophoresis Fragment Analysis）
Ningbo HEALTH Gene Technologies Co., LTD.
·
,
China
IVD General
CE/IVDD
Oncology Multi-Gene Mutations Detection Kit (High Throughput Sequencing)
Xiamen Spacegen Co., Ltd.
·
,
China
IVD General
CE/IVDD
Universal Sequencing Reaction Kit (Package II) E25 SM App-C FCL PE150
Qingdao MGI Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
Twist Precision Exome Dx Panel, 2 reactions
Twist Bioscience Corporation
·
,
United States
Class A
CE/IVDR
Universal Sequencing Reaction Kit T7 FCL SE100
Wuhan MGI Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
Vanadis Extract Bind and Wash kit
Wallac Oy
·
,
Finland
Class A
CE/IVDR
KMRtrack® KMR017
Genome Diagnostics B.V.
·
,
Netherlands
IVD General
CE/IVDD
Osteo-GeneSGKit 12 reacciones
Sistemas Genomicos. S.L.
·
,
Spain
IVD General
CE/IVDD
Colorectal Cancer Related Gene Mutation Detection Kit（High Throughput Sequencin…
Xiamen Spacegen Co., Ltd.
·
,
China
IVD General
CE/IVDD
Universal Sequencing Reaction Kit T7 HM App-D FCL PE150
Wuhan MGI Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
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