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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
Chromosomal disorders
W01060103
77 devices
Subcategories
7
W0106010301
Down's syndrome
2
devices
W0106010302
Edwards syndrome
0
devices
W0106010303
Klinefelter syndrome
0
devices
W0106010304
Pätau syndrome
0
devices
W0106010305
Turner syndrome
0
devices
W0106010306
Multiple detection of chromosomal disorders tests
6
devices
W0106010399
Chromosomal disorders tests - other
69
devices
Devices
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
Vanadis Core Reagent Cartridge II
Wallac Oy
·
,
Finland
Class C
CE/IVDR
CytoScan Dx Post-PCR 2°-8°C MOD S AH W PB
Affymetrix, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
BCR-ABL1(p210) %IS Kit (Digital PCR Method)
Suzhou Sniper Medical Technologies Co., Ltd.
·
,
China
IVD General
FDA 510(k)
K221869
Active
Cleared 5 Sep 2023
CE/IVDD
Chromosomal aneuploidies digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
ChromoQuant STaR Optima 1
Cybergene AB
·
,
Sweden
IVD General
CE/IVDD
Preimplantation Genetic Testing For Aneuploidy Detection Kit（Reversible Termina…
GeneMind Biosciences Co., Ltd.
·
,
China
IVD General
CE/IVDD
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