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In vitro diagnostic medical devices
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Genetic testing
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Acquired gene or chromosome alterations
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Tests for acquired genetic or chromosomal alterations - other
Tests for acquired genetic or chromosomal alterations - other
W01060299
579 devices
AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit
Amoy Diagnostics Co., LTD.
·
,
China
IVD General
CE/IVDD
Xl CCND3/Igh Df
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay
PentaBase A/S
·
,
Denmark
Class C
CE/IVDR
Xl ROS1-Gopc Ba
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
Oncobit PM NRASQ61L Control 10rxn
Oncobit AG
·
,
Switzerland
Class C
CE/IVDR
EZH2 mutation digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
SensiQuant Direct ABL MasterMix
Bioclarma S.R.L.
·
,
Italy
IVD General
CE/IVDD
Oncomine™ Dx Target Test (DNA and RNA Panel)
Life Technologies Limited
·
,
United States
Class C
CE/IVDR
TRUPCR® EGFR Kit
3B BlackBio Dx Limited
·
,
India
Class C
CE/IVDR
Human ROS1 Fusion Gene Detection Kit (PCR-Fluorescence Method)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Lymphoma NGS Panel
Genes 2Me Private Limited
·
,
India
IVD General
CE/IVDD
AmoyDx® EGFR 29 Mutations Detection Kit
Amoy Diagnostics Co., LTD.
·
,
China
IVD General
CE/IVDD
AmoyDx® EGFR 29 Mutations Detection Kit
Amoy Diagnostics Co., LTD.
·
,
China
IVD General
CE/IVDD
AmoyDx® ROS1 Gene Fusions Detection Kit
Amoy Diagnostics Co., LTD.
·
,
China
IVD General
CE/IVDD
Diagnostic Kit for Methylated Genes of Colorectal Cancer(Real Time PCR)
Excellen Medical Technology Co., Ltd.
·
,
China
Class C
CE/IVDR
Oncobit PM NRASQ61K Control 10rxn
Oncobit AG
·
,
Switzerland
Class C
CE/IVDR
MDM2 (12q15) - XL
Leica Biosystems Newcastle, Limited
·
,
United Kingdom
IVD General
CE/IVDD
OD002
OncoDNA
·
,
Belgium
IVD General
CE/IVDD
Index Set 16
4bases SA
·
,
Switzerland
Class A
CE/IVDR
geneMAP
Genmark Sağlik Ürünleri̇ İthalat İhracat Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
·
,
Türkiye
IVD General
CE/IVDD
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