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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
SensiQuant PML/RARa Standard BCR1
Bioclarma S.R.L.
·
,
Italy
IVD General
CE/IVDD
TRUPCR® HPV High Risk Genotyping Kit
3B BlackBio Dx Limited
·
,
India
Class C
CE/IVDR
CancerCheck 50 Panel
Genes 2Me Private Limited
·
,
India
IVD General
CE/IVDD
Human AML1-ETO Fusion Gene Detection Kit (Digital PCR Method)
Shenzhen Biorain biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
MYC Dual Color Break Apart Probe (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
AML1 (RUNX1) Breakapart Probe
Cytocell, Ltd.
·
,
United Kingdom
Class C
CE/IVDR
TRUPCR® MGMT Methylation Detection Kit
3B BlackBio Dx Limited
·
,
India
Class C
CE/IVDR
XL t(14 +1 more model
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
FOXO1 (13q14) Distal - XL
Leica Biosystems Newcastle, Limited
·
,
United Kingdom
IVD General
CE/IVDD
SensiQuant PML/RARa Positive Control BCR3
Bioclarma S.R.L.
·
,
Italy
IVD General
CE/IVDD
Oncobit PM NRASQ61L PPM 40rxn
Oncobit AG
·
,
Switzerland
Class C
CE/IVDR
MYC/BCL2/BCL6 Dual Color Break Apart Probe (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
BCL2/IGH Dual Color Dual Fusion Probe (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
XL t(15 +1 more model
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
ITK/SYK 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
IGH/MAF Plus v2 Translocation, Dual Fusion Probe
Cytocell, Ltd.
·
,
United Kingdom
Class C
CE/IVDR
Human Survival Motor Neuron 1 (SMN1) Gene Detection Kit (PCR-Melting Curve Meth…
Suzhou TianLong Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
PML-RARA Real-Time PCR Kit
Genes 2Me Private Limited
·
,
India
IVD General
CE/IVDD
UDI Primers Set 16
4bases SA
·
,
Switzerland
Class A
CE/IVDR
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