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In vitro diagnostic medical devices
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Reagents
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Genetic testing
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Genetic tests - other
Genetic tests - other
W010699
865 devices
Universal Sequencing Reaction Kit T7 HM FCL PE150
Wuhan MGI Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
Universal Library Preparation Kit
Xukang Medical Technology (Suzhou) Co., Ltd.
·
,
China
Class A
CE/IVDR
Salus Pro Sequencing Reagent Set
Shenzhen Salus BioMed Co.. Ltd
·
,
China
Class A
CE/IVDR
RARA Clinical Trial Assay (CTA)
Almac Diagnostic Services Limited Liability Company
·
,
United States
IVD General
CE/IVDD
Universal Sequencing Reaction Kit G400 HM FCL PE100
Wuhan MGI Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
PCR Master Mix
Biobase Diagnostic Technology (Shandong) Co., Ltd.
·
,
China
Class A
CE/IVDR
Nucleic Acid Extraction/Purification Reagent
Hangzhou New Horizon Health Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
PML-RARα L Detection Kit
Xiamen Zeesan Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
PML-RARα S Detection Kit
Xiamen Zeesan Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Magnetic Viral DNA/RNA Kit
Tiangen Biotech (Beijing) Co., Ltd.
·
,
China
Class A
CE/IVDR
GeneMind
GeneMind Biosciences Co., Ltd.
·
,
China
Class A
CE/IVDR
Universal Sequencing Reaction Kit (Package VII) T20 SM FCL PE150
Qingdao MGI Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
Droplex ESR1 Mutation Test
Gencurix, Inc.
·
,
South Korea
IVD General
CE/IVDD
Flow Cell Wash Kit
Qitan Taike Biotechnology Ltd., Chengdu
·
,
China
Class A
CE/IVDR
MiSeq™Dx Reagent Kit v3
Illumina, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
Onco-GeneSGKit 12 reacciones
Sistemas Genomicos. S.L.
·
,
Spain
IVD General
CE/IVDD
SureID®21G Human STR Identification Kit(Direct)
Ningbo HEALTH Gene Technologies Co., LTD.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 (ORF1ab, N and 211-212del) Detection Kit (Fluorescence PCR)
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Human BCR-ABL Gene T315I Mutation Detection Kit (Multiplex Fluorescence Polymer…
Xiamen Spacegen Co., Ltd.
·
,
China
IVD General
CE/IVDD
2019 Novel Coronavirus RNA Detection Kit (Multiplex Fluorescence Polymerase Cha…
Xiamen Spacegen Co., Ltd.
·
,
China
IVD General
CE/IVDD
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