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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 BCR3
Bioclarma S.R.L.
·
,
Italy
IVD General
CE/IVDD
TRUPCR® BCR-ABL Kit – Quantitative Major (WHO IS) Minor & Micro
3B BlackBio Dx Limited
·
,
India
Class C
CE/IVDR
Xl Igh/Mafb Df
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
TarCET Kit - Hereditary Cancer Panel
Medicover Genetics Limited
·
,
Cyprus
Class A
CE/IVDR
JAK2 V617F mutation digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
SensiQuant TEL-AML1 Positive Control
Bioclarma S.R.L.
·
,
Italy
IVD General
CE/IVDD
Sentosa SQ NSCLC Panel (4x8)
Vela Operations Singapore Pte. Ltd.
·
,
Singapore
IVD General
CE/IVDD
Lymphoid Leukemia NGS Panel
Genes 2Me Private Limited
·
,
India
IVD General
CE/IVDD
SensiQuant Direct ABL MasterMix
Bioclarma S.R.L.
·
,
Italy
IVD General
CE/IVDD
SensiQuant TEL-AML1 Standard
Bioclarma S.R.L.
·
,
Italy
IVD General
CE/IVDD
Craniopharyngioma-associated gene muation digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
Oncomine™ Solid Tumour DNA Kit (Part 2 of 2)
Life Technologies Limited
·
,
United States
IVD General
CE/IVDD
Oncobit PM GNA11Q209L Control 10rxn
Oncobit AG
·
,
Switzerland
Class C
CE/IVDR
RB1 Gene Deletion Probe Detection Kit (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
AmoyDx® Pan Lung Cancer PCR Panel
Amoy Diagnostics Co., LTD.
·
,
China
IVD General
CE/IVDD
MYC(8q24) Gene Amplification Probe Detection Kit (fluorescence in situ hybridiz…
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
ATM Deletion Probe
Cytocell, Ltd.
·
,
United Kingdom
Class C
CE/IVDR
CBFB Dual Color Break Apart Probe (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
SensiQuant Direct PML/RARa MasterMix BCR2
Bioclarma S.R.L.
·
,
Italy
IVD General
CE/IVDD
EasyPGX ready ESR1
Diatech Pharmacogenetics SRL
·
,
Italy
Class C
CE/IVDR
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