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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
TRUPCR® IDH1/2 Detection & Differentiation Kit
3B BlackBio Dx Limited
·
,
India
Class C
CE/IVDR
BCL2 (18q21) Break (tissue)
Leica Biosystems Newcastle, Limited
·
,
United Kingdom
IVD General
CE/IVDD
XL t(3 +1 more model
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
Devyser AZF v2
Devyser AB
·
,
Sweden
IVD General
CE/IVDD
MALT1 Dual Color Break Apart Probe (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
SensiQuant PML/RARa Positive Control BCR2
Bioclarma S.R.L.
·
,
Italy
IVD General
CE/IVDD
Human PIK3CA Gene Mutation Detection Kit (PCR-Fluorescence Method)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
SensiQuant PML/RARa Positive Control BCR1
Bioclarma S.R.L.
·
,
Italy
IVD General
CE/IVDD
Oncobit PM NRASQ61R PPM 40rxn
Oncobit AG
·
,
Switzerland
Class C
CE/IVDR
Human 6 Gene Methylation Detection Kit (PCR Fluorescent Probe Method)
Genetron Health (Beijing) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Oncomine™ Dx Express Test FFPE RNA Control
Life Technologies Limited
·
,
United States
IVD General
CE/IVDD
SensiScreen
PentaBase A/S
·
,
Denmark
IVD General
CE/IVDD
AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit
Amoy Diagnostics Co., LTD.
·
,
China
IVD General
CE/IVDD
MYC/BCL6/[CCND1/IGH][BCL2/IGH]Gene Probe Detection Kit (fluorescence in situ hy…
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Oncomine™ Dx Target RNA Control Diluent
Life Technologies Limited
·
,
United States
IVD General
CE/IVDD
GUDID
on market
EpiDirect® MGMT Methylation qPCR Assay
PentaBase A/S
·
,
Denmark
Class C
CE/IVDR
XL t(11 +1 more model
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
TOP2A Gene Amplification Probe Detection Kit (fluorescence in situ hybridizatio…
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
MYD88 L265P mutation digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
GeneMind
GeneMind Biosciences Co., Ltd.
·
,
China
IVD General
CE/IVDD
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