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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® HRD Complete Panel
Amoy Diagnostics Co., LTD.
·
,
China
IVD General
CE/IVDD
geneMAP
Genmark Sağlik Ürünleri̇ İthalat İhracat Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
·
,
Türkiye
IVD General
CE/IVDD
Ion Torrent™ Dx No Template Control Kit
Life Technologies Limited
·
,
United States
Class C
CE/IVDR
TRUPCR® ALL Panel Kit
3B BlackBio Dx Limited
·
,
India
Class C
CE/IVDR
FUS (16p11) Break
Leica Biosystems Newcastle, Limited
·
,
United Kingdom
IVD General
CE/IVDD
NUP98 Dual Color Break Apart Probe (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
UDI Primers Set B
4bases SA
·
,
Switzerland
Class A
CE/IVDR
XL t(6 +1 more model
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
BCL6/IGH Gene Fusion Probe Detection Kit (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
TRUPCR® NRAS Kit
3B BlackBio Dx Limited
·
,
India
Class C
CE/IVDR
XL 5q31/5q33/5p15
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
UDI Primers Set A
4bases SA
·
,
Switzerland
Class A
CE/IVDR
IUterusure
Wuhan Ammunition Life-tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Human BRAF Gene V600E Mutation Detection Kit (Digital PCR Method)
Shenzhen Biorain biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
ETV6 Dual Color Break Apart Probe (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
FKHR Dual Color Break Apart Probe (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Xl RB1/Dleu/Lamp
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
FUS(16p11) Dual Color Break Apart Probe (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
XCE 12 green
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
ctDNA Colorectal Panel
Genes 2Me Private Limited
·
,
India
IVD General
CE/IVDD
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