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In vitro diagnostic medical devices
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Reagents
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Genetic testing
Genetic testing
W0106
2,273 devices
Subcategories
4
W010601
Inborn gene or chromosome alterations
660
devices
›
W010602
Acquired gene or chromosome alterations
708
devices
›
W010603
Multiple parameters - genetic testing
40
devices
›
W010699
Genetic tests - other
865
devices
Devices
Rapid aneuploidy detection Kit
Xiamen Biofast Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Gene Probe Kit for DiGeorge Syndrome (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Vanadis Core T21/T18/T13 Reagent Cartridge
Wallac Oy
·
,
Finland
IVD Annex II List B
CE/IVDD
iSAFETM NIPT Kit with 6-color naica system:
Atila Biosystems Inc.
·
,
United States
Class C
CE/IVDR
Devyser Extend M1 v2
Devyser AB
·
,
Sweden
IVD General
CE/IVDD
Precon-GeneSGKit X 48 reacciones
Sistemas Genomicos. S.L.
·
,
Spain
IVD General
CE/IVDD
VeriSeq™ NIPT Sample Preparation Kit (24 samples)
Illumina, Inc.
·
,
United States
Class C
CE/IVDR
Niptify
Celvia CC AS
·
,
Estonia
IVD General
CE/IVDD
SHOX Gene Deletion Probe Detection Kit (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)
GeneMind Biosciences Co., Ltd.
·
,
China
IVD General
CE/IVDD
hvNIPT-GeneSGKit CE-IVD 48 Reacciones
Sistemas Genomicos. S.L.
·
,
Spain
IVD General
CE/IVDD
NIPT-GeneSGKit CE-IVD Advanced 12 Reacciones
Sistemas Genomicos. S.L.
·
,
Spain
IVD General
CE/IVDD
Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)
GeneMind Biosciences Co., Ltd.
·
,
China
IVD General
CE/IVDD
Devyser Compact
Devyser AB
·
,
Sweden
Class C
CE/IVDD
CE/IVDR
Chromosomal Copy Number Variation Testing Kit （Reversible Terminator Sequencing）
GeneMind Biosciences Co., Ltd.
·
,
China
IVD General
CE/IVDD
CytoScan Dx Wash Solution B
Affymetrix, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
CytoScan Dx Array, 6 pk
Affymetrix, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
Precon-GeneSGKit X 12 reacciones
Sistemas Genomicos. S.L.
·
,
Spain
IVD General
CE/IVDD
Bgi
Bgi Europe A/S
·
,
Denmark
IVD General
CE/IVDD
CytoScan Dx Wash Solution A
Affymetrix, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
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