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In vitro diagnostic medical devices
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Genetic testing
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Inborn gene or chromosome alterations
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Chromosomal disorders
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Chromosomal disorders tests - other
Chromosomal disorders tests - other
W0106010399
69 devices
LeoNext CfDNA Library Prep Kit
Genes 2Me Private Limited
·
,
India
IVD General
CE/IVDD
Devyser Compact
Devyser AB
·
,
Sweden
Class C
CE/IVDD
CE/IVDR
Chromosomal Copy Number Variation Testing Kit （Single Molecule Direct Sequencin…
GeneMind Biosciences Co., Ltd.
·
,
China
IVD General
CE/IVDD
Pregnancy loss detection Kit
Xiamen Biofast Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
CytoScan Dx Post-PCR -20°C MOD F L H
Affymetrix, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
NIPT-GeneSGKit CE-IVD 12 Reacciones
Sistemas Genomicos. S.L.
·
,
Spain
Class C
CE/IVDD
CE/IVDR
Pregnancy loss detection Kit
Xiamen Biofast Biotechnology Co., Ltd.
·
,
China
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
CytoScan Dx Pre-PCR 2°-8°C MOD T E W
Affymetrix, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
VeriSeq™ NIPT Sample Preparation Kit (48 samples)
Illumina, Inc.
·
,
United States
Class C
CE/IVDR
CytoScan Dx Post-PCR 15°-30°C MOD E PW
Affymetrix, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
CytoScan Dx Pre-PCR -20°C MOD R L A
Affymetrix, Inc.
·
,
United States
Class C
FDA De Novo
DEN130018
Active
Cleared 17 Jan 2014
CE/IVDR
+1
authorizations
Precon-GeneSGKit 12 reacciones
Sistemas Genomicos. S.L.
·
,
Spain
IVD General
CE/IVDD
NIPT-GeneSGKit CE-IVD Advanced 48 Reacciones
Sistemas Genomicos. S.L.
·
,
Spain
IVD General
CE/IVDD
Chromosome Aneuploidy and Copy Number Variants Detection Kit (Combinatorial Pro…
Bgi Europe A/S
·
,
Denmark
IVD General
CE/IVDD
Kawasaki IP-10 ELISA Kit
Xiamen Biofast Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Chromosome X/Y Probe Detection Kit (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
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