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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
TRUPCR® CALR Kit
3B BlackBio Dx Limited
·
,
India
Class C
CE/IVDR
TarCET Kit - Arrhythmia Panel
Medicover Genetics Limited
·
,
Cyprus
Class A
CE/IVDR
UDI Primers Set D
4bases SA
·
,
Switzerland
Class A
CE/IVDR
IDH1 mutation digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
TRUPCR® DPYD Mutations Detection Kit
3B BlackBio Dx Limited
·
,
India
Class C
CE/IVDR
ATM Gene Probe Detection Kit (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay
PentaBase A/S
·
,
Denmark
Class C
CE/IVDR
TRUPCR® KRAS Kit
3B BlackBio Dx Limited
·
,
India
Class C
CE/IVDR
XL CBFB/MYH11 plus
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
XL 20q12/20qter/8cen plus
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
Human 10-Gene Mutation Detection Kit
iCarbonX IntelliCore (Guangdong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
SensiScreen
PentaBase A/S
·
,
Denmark
IVD General
CE/IVDD
Del(7q) Deletion Probe
Cytocell, Ltd.
·
,
United Kingdom
Class C
CE/IVDR
Xl SPI1 Ba
Metasystems Probes GmbH
·
,
Germany
IVD General
CE/IVDD
Multi-Gene Methylation Detection Kit for Human Liver Cancer (PCR-Fluorescence P…
Singlera Genomics (Jiangsu) Ltd.
·
,
China
IVD General
CE/IVDD
NTRK1 Dual Color Break Apart Probe (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Ion Torrent™ Oncomine™ Dx Express Test Panel
Life Technologies Limited
·
,
United States
IVD General
CE/IVDD
GUDID
on market
SensiQuant Direct AML1-ETO MasterMix
Bioclarma S.R.L.
·
,
Italy
IVD General
CE/IVDD
Oncobit PM BRAF V600E Control 50rxn
Oncobit AG
·
,
Switzerland
Class C
CE/IVDR
11q23DLEU1 Gene Deletion Probe Detection Kit (fluorescence in situ hybridizatio…
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
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