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In vitro diagnostic medical devices
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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
Xa 13/21
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
Xa X/Y
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
STaR Optima 1
Cybergene AB
·
,
Sweden
IVD General
CE/IVDD
IONA® test M (including software)
Yourgene Health UK Ltd
·
,
United Kingdom
IVD Annex II List B
CE/IVDD
Nifty®
Bgi Europe A/S
·
,
Denmark
Class C
CE/IVDR
Yourgene® QST*R Base
Yourgene Health UK Ltd
·
,
United Kingdom
Class C
CE/IVDR
IONA® Test AR (including software)
Yourgene Health UK Ltd
·
,
United Kingdom
IVD Annex II List B
CE/IVDD
IONA® Nx cfDNA Library Prep Dx Kit (96) (including software)
Yourgene Health UK Ltd
·
,
United Kingdom
IVD Annex II List B
CE/IVDD
Chromosomal aneuploidies digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
Fetal Aneuploidies (Trisomy 21, Trisomy18 and Trisomy13) Detection Kit
CapitalBio Genomics Co., Ltd.
·
,
China
Class A
CE/IVDR
VeriSeq™ NIPT Sample Prep Kit (96 samples)
Illumina, Inc.
·
,
United States
Class C
CE/IVDR
Agile-NIPT for MGI CE-IVD 48 Reacciones.
Sistemas Genomicos. S.L.
·
,
Spain
IVD General
CE/IVDD
Preimplantation Genetic Testing For Aneuploidy Detection Kit（Single Molecule Di…
GeneMind Biosciences Co., Ltd.
·
,
China
IVD General
CE/IVDD
Male factor infertility detection Kit
Xiamen Biofast Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Y Chromosome Microdeletion Detection Kit (PCR-Capillary Electrophoresis)
Yaneng BIOscience (Shenzhen) Co., Ltd.
·
,
China
IVD General
CE/IVDD
ChromoQuant AZF
Cybergene AB
·
,
Sweden
IVD General
CE/IVDD
NIPT-GeneSGKit CE-IVD 48 Reacciones
Sistemas Genomicos. S.L.
·
,
Spain
IVD General
CE/IVDD
Chromosomal aneuploidies digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
Preimplantation Genetic Testing For Aneuploidy Detection Kit（Single Molecule Di…
GeneMind Biosciences Co., Ltd.
·
,
China
IVD General
CE/IVDD
Chromosomal aneuploidies digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
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