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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
CBFB/MYH11 Gene Fusion Probe (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Oncomine™ Dx Target Test (DNA and RNA Panel)
Life Technologies Limited
·
,
United States
IVD General
CE/IVDD
GUDID
on market
XL DLEU/LAMP/12cen
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
IGH/MAF Plus v2 Translocation, Dual Fusion Probe
Cytocell, Ltd.
·
,
United Kingdom
Class C
CE/IVDR
Human BRAF Gene V600E Mutation Detection Kit (PCR-Fluorescence Method)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Super-ARMS® EGFR Mutation Detection Kit
Amoy Diagnostics Co., LTD.
·
,
China
IVD General
CE/IVDD
IGH/MALT1 Gene Fusion Probe Detection Kit (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
geneMAP
Genmark Sağlik Ürünleri̇ İthalat İhracat Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
·
,
Türkiye
IVD General
CE/IVDD
TRUPCR® BCR-ABL1 Kit - Quantitative Major (WHO IS)
3B BlackBio Dx Limited
·
,
India
Class C
CE/IVDR
EZH2 mutation digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
FUS (16p11) Proximal - XL
Leica Biosystems Newcastle, Limited
·
,
United Kingdom
IVD General
CE/IVDD
BCR-ABL Universal Real Time PCR Kit
Genes 2Me Private Limited
·
,
India
IVD General
CE/IVDD
ABL1/ABL2/PDGFRB/CRLF2/JAK2 Gene Break Apart Probe (fluorescence in situ hybrid…
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Human JAK2 Gene V617F Mutation Detection Kit (Digital PCR Method)
Suzhou Precigenome Ltd, Co;
·
,
China
IVD General
CE/IVDD
TarCET Kit Metabolic Panel
Medicover Genetics Limited
·
,
Cyprus
Class A
CE/IVDR
geneMAP
Genmark Sağlik Ürünleri̇ İthalat İhracat Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
·
,
Türkiye
IVD General
CE/IVDD
AmoyDx® Pan Lung Cancer PCR Panel
Amoy Diagnostics Co., LTD.
·
,
China
IVD General
CE/IVDD
AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit
Amoy Diagnostics Co., LTD.
·
,
China
IVD General
CE/IVDD
Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencin…
GeneMind Biosciences Co., Ltd.
·
,
China
IVD General
CE/IVDD
TRUPCR® MPL Kit
3B BlackBio Dx Limited
·
,
India
Class C
CE/IVDR
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