Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
In vitro diagnostic medical devices
/
Reagents
/
Genetic testing
/
Inborn gene or chromosome alterations
/
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
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
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
Previous
Next