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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
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
YCM-Q Real Time PCR Kit (Y Chromosome Microdeletion)
Genes 2Me Private Limited
·
,
India
IVD General
CE/IVDD
Rapid aneuploidy detection Kit
Xiamen Biofast Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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
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